Randomized, Double-blind, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of HX575 Epoetin Alfa vs. US Licensed Epoetin Alfa (Epogen®/Procrit®) in the Treatment of Anemia Associated With Chronic Kidney Disease

The purpose of this study is to show biosimilarity of HX575 epoetin alfa with the US licensed reference product Epogen®/Procrit® when applied subcutaneously. This study is intended to generate data supporting that the efficacy and safety under treatment with HX575 and Epogen®/Procrit® are comparable.

Start Date01 Sep 2012

Sponsor / Collaborator

Sandoz Group AG

NCT01576341

/ CompletedPhase 3

Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of HX575 Epoetin Alfa in the Treatment of Anemia Associated With Chronic Kidney Disease in Pre-dialysis and Dialysis Patients

The study will assess the immunogenicity, safety, and efficacy of HX575 epoetin alfa administered subcutaneously (s.c.) in patients suffering from anemia due to chronic kidney disease (CKD)

Start Date01 Apr 2012

Sponsor / Collaborator

Sandoz Group AG

NCT01034657

/ TerminatedPhase 2

A One Year, Open Label, Multicenter Trial of LBH589 Alone or in Combination With ESA in Red Blood Cell Transfusion-dependent LOW and INT-1 MDS Patients Being Either Refractory to ESA or With a Low Probability of Response - the GErman PAnobinostat Low Risk MDS Trial - GEPARD Study

This study assessed the efficacy and safety of LBH589 as single agent and in combination with ESA in red blood cell transfusion-dependent Low and Int-1 MDS patients being either refractory to ESA or with a low probability of response. The study had a non-randomized core phase followed by a randomized phase.

Start Date01 Nov 2009

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

100 Clinical Results associated with Epoetin alfa(Sandoz International GmbH)

100 Translational Medicine associated with Epoetin alfa(Sandoz International GmbH)

100 Patents (Medical) associated with Epoetin alfa(Sandoz International GmbH)

Literatures (Medical) associated with Epoetin alfa(Sandoz International GmbH)

01 Jan 2023·Critical reviews in oncology/hematology

Epoetin alfa biosimilar (HX575): A review of 15 years’ post-approval clinical experience

Review

Author: Zabransky, Markus ; Gascón, Pere ; Goldsmith, David ; Esmael, Altaher ; Dellanna, Frank ; Aapro, Matti

Biosimilars offer the potential to expand patient access and reduce healthcare costs. Therefore, it is of importance that clinicians and patients are reassured about their efficacy and safety in practice. In 2007, Binocrit® (HX575; Sandoz GmbH, Kundl, Austria) was the first epoetin alfa biosimilar approved for use in chemotherapy induced anaemia (CIA), chronic renal failure (CRF), and more recently myelodysplastic (MDS) anaemia. Since its approval, there has been a plethora of data demonstrating the well-tolerated safety profile of HX575. This review will outline the safety results collected from key studies that have added to the extensive HX575 (Binocrit® unless otherwise stated) clinical experience. With a focus on all approved indications, we will review the safety data collected across a range of study types, to further consolidate the reassurance for the use of HX575 in these indications.

01 Feb 2020·Journal of pharmaceutical and biomedical analysis

Glycan analysis of erythropoiesis-stimulating agents

Article

Author: Hakkarainen, Birgit ; Mulugeta, Ezra ; Cowper, Ben ; Lavén, Martin

Erythropoiesis stimulating agents (ESAs) are a group of therapeutic glycoproteins used to treat anaemia caused by chronic kidney disease or chemotherapy. A variety of ESA products are available in the European Union, including innovator, biosimilar and second-generation medicines. Glycosylation is a critical quality attribute of ESA products, as it has a crucial influence upon in vivo biological activity. In this study, a combination of chromatography and mass spectrometry analysis has been used to characterise and compare the glycosylation profiles of five ESA products; Eprex® (epoetin alfa), NeoRecormon® (epoetin beta), Binocrit® (epoetin alfa biosimilar), Silapo (epoetin alfa biosimilar) and Aranesp® (darbepoetin alfa). The methods utilised include mixed-mode anion-exchange/hydrophilic interaction chromatography (AEX/HILIC-MS) for N-glycan identification and quantitation, and HILIC-MS for O-glycan characterisation. The products exhibit notable differences in N- and O-glycosylation, including attributes such as sialic acid occupation, O-acetylation, N-acetyllactosamine extended antennae and sulphated/penta-sialylated N-glycans, which have the potential to cause divergence of therapeutic potencies. The study highlights the need for continued monitoring of ESA product glycosylation, ideally allied to pharmacological data, in order to ensure consistency and therapeutic equivalence between products and enhance our understanding of ESA structure-activity-relationships.

01 Sep 2019·Kidney international reports

Will There Be a Role for a Short-Acting Biosimilar Erythropoiesis-Stimulating Agent in US Nephrology Practice?

Author: Wish, Jay B

See Clinical Research on Page 1235 See Clinical Research on Page 1235 Patent protection for pharmaceuticals in the United States is very robust and perhaps there is no greater example than epoetin alfa. Since the approval of epoetin alfa by the Food and Drug Administration (FDA) in 1989, the developer, Amgen (Thousand Oaks, CA), has successfully defended its patent against competing agents, such as epoetin beta (Chugai-Upjohn, Rosemont, IL), epoetin delta (Shire, Lexington, MA), and methoxy polyethylene glycol-epoetin beta (CERA; Roche, Basel, Switzerland). The US patent on epoetin alfa expired in 2015, opening the way for competition by products other than Amgen’s own darbepoetin. The first non-Amgen erythropoiesis-stimulating agent (ESA) to enter the US market was CERA, which had previously been approved by the FDA as a new drug under a biologic license application 351(a). Drugs approved through the 351(a) pathway must undergo expensive clinical testing, the cost of which is ultimately passed on to the consumer. ESAs are biologic drugs, defined by the FDA as “a virus, therapeutic serum, toxin, antitoxin, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product . . . applicable to the prevention, treatment of cure of a disease or condition of human beings.” Because they are more structurally complex than small-molecule drugs, biologics are considerably more expensive to develop and produce; those costs also are passed on to the consumer, which limits patient access to important therapeutic agents. A biosimilar agent is defined by the FDA as “a biologic that is highly similar to the reference or originator product, with no clinically meaningful differences in terms of the safety, purity, and potency regardless of minor differences in clinically inactive components.” Biosimilar agents also are expensive to produce, but some of their cost can be decreased by an expedited regulatory approval process in the United States: the biologic license application for biosimilar agents, 351(k) enacted in 2009, which decreases the time and cost burden of the extensive clinical testing required under the 351(a) pathway. The 351(k) pathway is based on the “comparability principle”: if A leads to C, and B is comparable to A, then B leads to C. The burden on the developer of a biosimilar agent is to demonstrate structural, functional, pharmacokinetic, and pharmacodynamic high similarity with the reference biologic. If this is achieved, the 351(k) pathway allows for a significantly lower burden of clinical trial data than that was required for the reference biologic under the 315(a) pathway.1Wish J.B. The approval process for biosimilar erythropoiesis stimulating agents.Clin J Am Soc Nephrol. 2014; 9: 1645-1651Crossref PubMed Scopus (12) Google Scholar The enactment of the 351(k) pathway in the United States was driven by very favorable results of a similar pathway to expedite the approval process of lower-cost biosimilar agents in the European Union (EU) where patent protection is not as robust as in the United States. The first biosimilar ESAs were approved in the EU in 2007; it has been estimated that the use of these agents has led to 15% to 30% cost savings versus originator ESAs.2Singh S.C. Bagnato K.M. The economic implications of biosimilars.Am J Manag Care. 2015; 21: s331-s340PubMed Google Scholar The primary safety concern with ESAs in general, and biosimilar ESAs in particular, is pure red cell aplasia (PRCA), which results from the development of antibodies against the ESA that cross react with native erythropoietin, leading to the loss of red blood cell precursors in the bone marrow and severe anemia. PRCA has been a significant issue in countries with poor regulation of pharmaceuticals where biosimilar-like (not truly biosimilar by the strict definition of the word) ESAs have entered the market without adequate safeguards regarding manufacturing, packaging, and distribution. Praditpornsilpa et al.3Praditpornsilpa K. Kupatawintu P. Jootar S. et al.The immunogenicity of biosimilar recombinant human erythropoietin (r-HuEpo) administered by subcutaneous injection for the treatment of anemia in patients with chronic kidney disease.Kidney Int. 2011; 80: 88-92Abstract Full Text Full Text PDF PubMed Scopus (93) Google Scholar noted an alarming increase in the prevalence of PRCA in Thailand to 1 in 2068 patients at risk, concomitant with the higher penetration of poorly regulated biosimilar-like epoetins into the market. Such reports have undeservedly tarnished the excellent safety record of true biosimilar ESAs. Nonetheless, clusters of PRCA have been associated with originator ESAs and biosimilar ESAs, usually attributable to packaging issues and not to the inferiority of the ESA molecule. Eprex, an originator epoetin alfa product sold in Europe, was associated with a PRCA cluster that was attributed to the interaction between polysorbate-80 (a stabilizer that replaced human albumin because of concerns regarding prion transmission by a human protein) and the rubber in the gasket of prefilled syringes. Once the problem was identified and the gasket was coated with latex, the cluster of PRCA was arrested.4Boven K. Stryker S. Knight J. et al.The increased incidence of pure red cell aplasia with an Eprex formulation in uncoated rubber stopper syringes.Kidney Int. 2005; 67: 2346-2353Abstract Full Text Full Text PDF PubMed Scopus (216) Google Scholar Two cases of PRCA occurred with a biosimilar version of epoetin alfa approved in the EU, Binocrit, which interacted with tungsten used to manufacture prefilled syringes.5Seidl A. Hainzl O. Richter M. et al.Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity.Pharm Res. 2012; 29: 1454-1467Crossref PubMed Scopus (149) Google Scholar Virtually all cases of PRCA occur with subcutaneous (s.c.) administration of the ESA. Following their respective PRCA clusters, s.c. administration of Eprex was contraindicated from 2002 to 2006, and the EU withheld approval for s.c. administration of Binocrit from 2008 to 2016. Therefore, it is vitally important for all newly approved ESAs to demonstrate their safety when administered s.c., particularly with regard to immunogenicity. In this issue of KI Reports, Fishbane et al.6Fishbane S. Spinowitz B.S. Wisemandle W.A. Martin N.E. Randomized controlled trial of subcutaneous epoetin alfa-epbx versus epoetin alfa in end-stage kidney disease.Kidney Int Rep. 2019; 4: 1235-1247Abstract Full Text Full Text PDF Scopus (4) Google Scholar describe the results of phase 3 testing of a biosimilar epoetin alfa administered s.c. in hemodialysis patients as part of the US FDA approval process through the 351(k) pathway. This biosimilar epoetin alfa has been designated epoetin alfa-epbx by the nomenclature system recently announced by the FDA to distinguish multiple biosimilars from each other and from the reference product to promote pharmacovigilance. The agent was known as epoetin-hospira during the FDA approval process and has taken the brand name Retacrit in the United States, which is the same as its brand name in the EU, where it was approved in 2007 for both i.v. and s.c. administration. It was approved by the FDA on May 15, 2018, for i.v. and s.c. administration. The results of phase 3 testing of i.v.-administered epoetin alfa-epbx versus originator epoetin alfa in hemodialysis patients have previously been published7Fishbane S. Singh B. Kumbhat S. et al.Intravenous epoetin alfa-epbx versus epoetin alfa for treatment of anemia in end-stage kidney disease.Clin J Am Soc Nephrol. 2018; 13: 1204-1214Crossref PubMed Scopus (12) Google Scholar and reveal no significant efficacy or safety differences between the 2 products. In the i.v. study of 612 patients, 5 tested positive for anti-recombinant human erythropoietin antibodies at baseline, and 2 additional patients (1 per study arm) developed anti-recombinant human erythropoietin antibodies while on study treatment. All patients tested negative for neutralizing antibodies, and no patient in either group experienced an event of PRCA. The s.c. study was required by the FDA because, as noted previously, the development of neutralizing antibodies and PRCA occurs almost exclusively in patients treated with s.c. ESAs. In the s.c. study,6Fishbane S. Spinowitz B.S. Wisemandle W.A. Martin N.E. Randomized controlled trial of subcutaneous epoetin alfa-epbx versus epoetin alfa in end-stage kidney disease.Kidney Int Rep. 2019; 4: 1235-1247Abstract Full Text Full Text PDF Scopus (4) Google Scholar investigators randomized 246 hemodialysis patients who had previously been treated with epoetin alfa (i.v. or s.c.) to s.c. epoetin alfa-epbx or s.c. originator epoetin alfa. They were followed for 16 weeks on study drug; again, efficacy and safety were comparable between the 2 study arms. Three patients (1 treated with epoetin alfa-epbx and 2 treated with reference epoetin alfa) developed anti-recombinant human erythropoietin antibodies while receiving study drug; however, no patient in either treatment arm developed neutralizing antibodies, PRCA, or hypersensitivity consistent with immunogenic response to epoetin. Despite reassurance regarding the lack of neutralizing antibody or PRCA development with a biosimilar ESA such as epoetin alfa-epbx in a highly regulated environment such as the United States or EU, there may be nephrologists who take a conservative approach to the adoption of such agents pending postmarketing experience with many more patients over longer periods of time. They cite the experience with peginesatide, a PEGylated peptide with erythropoietin receptor activity (not a biosimilar protein) that was voluntarily recalled following 49 cases of anaphylaxis-like reactions, including 7 fatalities. These reactions occurred exclusively with the multidose vial formulation of peginesatide, leading to suspicion that an interaction between one of the preservatives and the drug led to its immunogenicity.8Kotarek J. Stuart C. De Paoli S.H. et al.Subvisible particle content, formulation, and dose of an erythropoietin peptide mimetic product are associated with severe adverse postmarketing events.J Pharm Sci. 2016; 105: 1023-1027Abstract Full Text Full Text PDF PubMed Scopus (82) Google Scholar Although peginesatide was not a biosimilar, there remains some confusion if not distrust of the biosimilar category of agents because they have not undergone the same preapproval vetting by the FDA as originator biologics. To address these and other concerns regarding the use of biosimilar agents in nephrology, the National Kidney Foundation held a workshop in 2015 to demystify this class of agents and to provide context regarding their adoption.9Wish J.B. Charytan C. Chertow G.M. et al.Introduction of biosimilar therapeutics into nephrology practice in the United States: report of a scientific workshop sponsored by the National Kidney Foundation.Am J Kidney Dis. 2016; 68: 843-852Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar The workgroup acknowledged the need for evidence-based education of providers and patients regarding the advantages (primarily lower cost to patients and the health care system) and disadvantages (unknown risks due to relative lack of clinical experience with fewer patients over shorter duration) of biosimilars versus originator products; the need for postmarketing pharmacovigilance of at least 2 to 4 years (as is done in the EU) to detect safety issues that were not apparent in registration studies; the need for postmarketing studies with patient-reported outcomes that inform choice of therapeutic agent; and the need for increased clarity from the FDA regarding such issues as biosimilar interchangeability, substitution, and extrapolation. Epoetin alfa-epbx does not have an interchangeability designation (a designation the sponsor did not seek), so the pharmacist or prescription drug plan cannot substitute the biosimilar for the originator agent without informing the prescriber. Nonetheless, many prescription drug plans in the United States now have a prior approval process for ESAs that requires the prescriber to use epoetin alfa-epbx as first-line therapy for anemia in patients with non–dialysis-dependent chronic kidney disease. For patients on dialysis, the choice of ESA is driven by the formulary of the dialysis provider. In the United States, the 2 largest dialysis providers have long-term contracts for originator ESAs, so that leaves only 20% of the dialysis market open to penetration by a biosimilar product. Of note is a recent observational study from Japan that suggests the use of shorter-acting ESAs (epoetin alfa, epoetin beta, and a biosimilar of epoetin alfa) was associated lower death rates from all causes, cardiovascular disease, cardiac disease, stroke, non-cardiovascular disease, stroke, and malignancy, than longer-acting ESAs (darbepoetin and CERA).10Sakaguchi Y. Hamano T. Wada A. Masakane I. Types of erythropoietin-stimulating agents and mortality among patients undergoing hemodialysis.J Am Soc Nephrol. 2019; 30: 1037-1048Crossref PubMed Scopus (43) Google Scholar The reason for this difference in outcomes is unclear, but a perception that shorter-acting ESAs are safer could accelerate the adoption of the shorter-acting epoetin alfa-epbx over longer-acting alternatives that are also more expensive. The timeline of ESAs currently available in the United States and EU is shown in Figure 1. The future of all originator and biosimilar ESA therapy is unclear following the potential approval of the hypoxia-inducible factor stabilizer class of drugs, which are orally administered and often effective in patients who are ESA resistant. The oral route of hypoxia-inducible factor stabilizer administration may have the greatest appeal among non-hemodialysis patients, especially those who would otherwise be injecting shorter-acting ESAs, such as epoetin and its biosimilars. However, the value proposition of the hypoxia-inducible factor stabilizers has yet to be clarified, as pricing and long-term safety are not established. The safety of s.c.-administered epoetin alfa-epbx reported in this issue of KI Reports provides reassurance to prescribers, payers, and patients that this new less expensive option in the United States for the treatment of anemia of chronic kidney disease has a place in the current ESA-based paradigm. JBW is a consultant/advisory board member for AstraZeneca, Akebia, Vifor, and Rockwell Medical. He previously served as a consultant to Hospira/Pfizer. He is on the speaker’s bureau for Akebia. Randomized Controlled Trial of Subcutaneous Epoetin Alfa-epbx Versus Epoetin Alfa in End-Stage Kidney DiseaseKidney International ReportsVol. 4Issue 9PreviewThis double-blind, randomized controlled trial compared the safety and efficacy of subcutaneous epoetin alfa-epbx, an epoetin alfa biosimilar, with the reference product, epoetin alfa, in hemodialysis patients with end-stage kidney disease (ESKD) and anemia who were receiving epoetin alfa maintenance treatment. Full-Text PDF Open Access

News (Medical) associated with Epoetin alfa(Sandoz International GmbH)

29 Apr 2026

·www.sandoz.com

Sandoz reports strong biosimilars growth in Q1 2026; full-year 2026 guidance confirmed

Basel, 29 April 2026 – Sandoz (SIX: SDZ/OTCQX: SDZNY), the global leader in affordable medicines, today presents its net-sales performance for the first quarter of 2026. Q1 2026 % Q1 2025 Change USD m Net sales USD m USD % CC %1,2,3 Net sales 2,756 100% 2,480 11% 3% Biosimilars 853 31% 671 27% 18% Generics 1,903 69% 1,809 5% -3% Europe 1,556 57% 1,372 13% 2% International 609 22% 590 3% -2% North America 591 21% 518 14% 12% Performance in line with Company expectations. Overall net sales up by 3% at CC, and by 5% when excluding effect of adverse dynamics in anti-infective B2B business4. Impact of dynamics in year concentrated in first quarter, with remaining effects dissipating thereafter Biosimilar net sales up by 18% at CC, with generics net sales declining by 3% at CC. Underlying generics net sales declined by 1% at CC when excluding aforementioned anti-infective B2B impact North America net sales up by 12% at CC, reflecting exceptional biosimilars performance. Europe net sales up by 2% at CC with biosimilars net sales up by double digit. Excluding anti-infective B2B impact, Europe net sales up by 4% at CC. Exceptional International biosimilar net sales, with region’s generics result impacted by active portfolio rationalisation and phasing of sales, as well as anti-infective B2B effect Announcement of strategic partnership with Samsung Bioepis, covering up to five biosimilar assets Full-year 2026 guidance confirmed Richard Saynor, Chief Executive Officer of Sandoz, commented: “The performance in the first quarter illustrates the underlying strengths of Sandoz. I was delighted by the exceptional growth in North America and International across biosimilars, supported by new launches and excellence in execution. We produced sales growth in line with our expectations, and the fundamentals of the 2026 roadmap are strong. We are happy to confirm our full-year guidance today. “As we look further out, I’m excited by the overwhelming scale of the opportunities ahead. We’ll complete the construction of our biosimilar hub soon; we’re rapidly expanding the biosimilar pipeline; regulatory streamlining is an important tailwind, and a very significant number of losses of exclusivity are approaching. More than 20,000 Sandoz colleagues are ready to capitalise on these opportunities and deliver even more for patients and shareholders.” BUSINESS HIGHLIGHTS In March 2026, Sandoz and Samsung Bioepis entered a strategic partnership covering up to five biosimilar assets, with the first being a proposed vedolizumab biosimilar. The agreement expands the Sandoz biosimilar pipeline to up to 32 assets In the period, the Company focused its biosimilar development, manufacturing and supply activities under newly appointed Armin Metzger. This will drive faster decision making, greater vertical integration and improved launch readiness across the expanding biosimilars pipeline. There are no changes to the Company’s financial-reporting structure The European Medicines Agency (EMA) recently confirmed that, for well‑characterised biological medicines, a robust analytical comparability package, combined with comparative pharmacokinetic data, may be sufficient to demonstrate biosimilarity, and comparative clinical efficacy and safety studies are not necessarily required. The EMA commented, “this tailored clinical approach is expected to be applicable for the majority of biosimilar candidates” In March 2026, the US FDA expanded the label for Enzeevu® (aflibercept) to include macular edema following retinal vein occlusion, diabetic retinopathy and diabetic macular edema, along with the previously approved indication of neovascular (wet) age-related macular degeneration. This significantly broadened the treatable patient population and supports a planned Q4 2026 US launch In the period, the European Commission granted marketing authorisation for Ranluspec® (ranibizumab) across all reference indications, reinforcing the Company’s ophthalmology franchise and paving the way for an expected H2 2026 European launch In April2026, following a Commerce Department investigation, the US government confirmed that generic and biosimilar medicines “should not be subject to section 232 tariffs at this time” During the period, the Company announced the issuance of a CHF 275 million bond with a six-year maturity and a CHF 275 million bond with a 10-year maturity, for the refinancing of maturing debt and other general corporate purposes. Sandoz is on track to extend its average debt maturity to six to seven years FULL-YEAR 2026 GUIDANCEThe Company continues to anticipate strong net-sales growth and further core EBITDA-margin expansion this year. As a result, the Company confirms its guidance for 2026: Net sales to grow at CC by a mid-to-high single-digit percentage Core EBITDA-margin expansion of around 100 basis points No material contribution from any potential launch of generic semaglutide is expected in 2026, while overall pricing is expected to decline by a low-to-mid single-digit percentage. The guidance excludes any impacts of unforeseen events or unconfirmed developments, including the imposition of new tariffs emanating from the US government. CONFERENCE CALL A conference call and webcast for investors and analysts will begin today at 9.30am CET. Details can be found here, with the accompanying presentation here. NOTES The performance shown in this Media Release covers the three-month period ended 31 March 2026 (Q1 2026), compared to the three-month period ended 31 March 2025 (Q1 2025). In this Media Release, ‘Company’ refers to Sandoz Group AG. Over one billion patients were reached by Sandoz in 2025, including an estimated 0.2 billion patients reached through API sales. CALENDARThe Company intends to publish its half-year results on 5 August 2026.DISCLAIMERThis Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialise or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law. REFERENCES1 Constant currencies. 2 Non-IFRS measures are defined in the Supplementary financial information section of the Integrated Annual Report 2025. 3 For Q1 2026, all growth at constant currencies is the same as the comparable growth rate. Sandoz defines the comparable growth rate (CGR) as the growth rate of net sales at CC excluding the effects of material acquisitions and divestments. In the case of divestments, net sales are excluded for the corresponding period. Similarly, for acquisitions, the relevant net sales are excluded for the corresponding period. Material acquisitions and divestments are transactions in scope of significant transactions in the Company’s consolidated financial statements. Sandoz believes the presentation of CGR is meaningful for management and investors to evaluate the performance of the business over time. 4 As part of its vertically integrated penicillin production, the Company sells certain amounts of active pharmaceutical ingredients (APIs) on a business-to-business (B2B) basis. The imposition of tariffs by the US government in 2025 led to reduced exports from China to the US, prompting Chinese suppliers to significantly lower global prices for key penicillin APIs, including 6 Aminopenicillanic acid (6 APA), the foundational compound for all penicillin. This price decline coincided with an increase in global market supply. Penicillin API represented a significant part of anti-infective B2B net sales in FY 2025. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 colleagues of 100 nationalities work together to ensure over one billion patients are reached by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 medicines addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. In 2026, Sandoz celebrates 20 years of pioneering biosimilars, 80 years of antibiotics manufacturing and 140 years of heritage. In 2025, Sandoz recorded net sales of USD 11.1 billion. CONTACTS Global Media Relations contacts Investor Relations contacts Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Alexis Kalomparis +41 79 279 0285 Craig Marks +44 7818 942 383 Chris Lewis +49 174 244 9501 Tamara Hackl +41 79 790 5217 Gregor Rodehueser +49 170 574 3200 Silvia Siegfried +41 79 795 9061 FIRST-QUARTER NET SALES Net sales of USD 2,756 million in the quarter represented growth of 3% at CC. Volumes grew by 7%, partly offset by price erosion of 4%. Net-sales growth was primarily driven by the performance of biosimilars, which continue to benefit from an extensive launch programme. When excluding the impact of adverse dynamics in the anti-infective B2B business, the growth in net sales amounted to 5% at CC. By business Q1 2026 Q1 2026 % Q1 2025 change USD m Net sales USD m USD % CC % CGR % Net sales 2,756 100% 2,480 11% 3% 3% Biosimilars 853 31% 671 27% 18% 18% Generics 1,903 69% 1,809 5% -3% -3% Biosimilars overview Net sales of biosimilars of USD 853 million reflected a strong growth of 18% at CC. Biosimilars represented 31% of total net sales (Q1 2025: 27%). The Europe biosimilars performance benefited from the launch of Afqlir® (aflibercept) and good performances from Hyrimoz® (adalimumab) and Binocrit® (epoetin alfa). Exceptional North America biosimilar net-sales growth reflected the strong launch of Wyost® & Jubbonti® (denosumab), while an exceptional International biosimilar result was driven by the performances of Hyrimoz, Rixathon® (rituximab) and the recent launches of Wyost & Jubbonti. Generics overview Net sales of generics of USD 1,903 million reflected a decline of 3% at CC and, when excluding the impact of adverse dynamics in the anti-infective B2B business, this translated to a decrease of 1% at CC. Generics represented 69% of net sales (Q1 2025: 73%). The decline in net sales was mainly driven by the performance in the International business which was significantly impacted by active portfolio rationalisation and the phasing of sales, as well as the aforementioned anti-infective B2B effect. By region Q1 2026 Q1 2026 % Q1 2025 change USD m Net sales USD m USD % CC % CGR % Net sales 2,756 100% 2,480 11% 3% 3% Europe 1,556 57% 1,372 13% 2% 2% International 609 22% 590 3% -2% -2% North America 591 21% 518 14% 12% 12% Europe overview Net sales in Europe were USD 1,556 million, reflecting growth of 2% at CC, with a double-digit biosimilars performance at CC outweighed by a decline in generics net sales, with the latter impacted by the effect of adverse dynamics in the anti-infective B2B business. This performance was also driven by unfavourable seasonal effects on the sale of antibiotics and over-the-counter cold & cough medicines, alongside the impacts of market dynamics in Germany, price erosion and healthcare-policy changes in France. International overview Net sales in International were USD 609 million, a decline of 2% at CC. Biosimilars delivered an exceptional performance, driven by Hyrimoz, Rixathonand the recent launches of Wyost & Jubbonti. Generics net sales decreased at CC, primarily due to active portfolio rationalisation and the phasing of sales, as well as the impact of adverse dynamics in the anti-infective B2B business. North America overview Net sales in North America were USD 591 million, representing growth of 12% at CC. An exceptional biosimilar result was driven by the strong launches of Wyost & Jubbonti. Generics net-sales growth was driven by recent US launch of lisdexamfetamine and the performance of estradiol. The Company provides the net-sales performance by region by business at each half-year and full-year results. APPENDIX QUARTERLY 2025 NET SALES BY BUSINESS Q1 2025 change Q2 2025 change Q3 2025 change Q4 2025 change USD m USD % CC % USD m USD % CC % USD m USD % CC % USD m USD % CC % Biosimilars 671 8% 11% 825 15% 12% 862 16% 13% 934 21% 16% Generics 1,809 -3% 0% 1,927 5% 2% 1,963 6% 3% 2,095 8% 2% Net sales 2,480 0% 3% 2,752 8% 5% 2,825 9% 6% 3,029 12% 6% BY REGION Q1 2025 change Q2 2025 change Q3 2025 change Q4 2025 change USD m USD % CC % USD m USD % CC % USD m USD % CC % USD m USD % CC % Europe 1,372 3% 7% 1,460 12% 6% 1,530 12% 6% 1,574 15% 6% International 590 -8% -2% 694 11% 11% 659 4% 4% 770 18% 14% North America 518 -1% 1% 598 -4% -3% 636 6% 7% 685 -1% -2% Net sales 2,480 0% 3% 2,752 8% 5% 2,825 9% 6% 3,029 12% 6% Investors Media Patients & Caregivers Partners (B2B) Job seekers Suppliers Contacts Our policies Transparency Careers Sandoz Site Directory Report Adverse Event Medical inquiry SpeakUp Email subscription 1 A Pharma Hexal Lek Investors Media Patients & Caregivers Partners (B2B) Job seekers Suppliers Contacts Our policies Transparency Careers Sandoz Site Directory Report Adverse Event Medical inquiry SpeakUp Email subscription 1 A Pharma Hexal Lek

Biosimilar

25 Feb 2026

·www.sandoz.com

Sandoz delivers strong full-year results; guidance for 2026 reflects an expected acceleration in growth

Ad-hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules Media Release Sandoz delivers strong full-year results; guidance for 2026 reflects an expected acceleration in growth Basel, February 25, 2026 – Sandoz (SIX: SDZ; OTCQX: SDZNY), the global leader in affordable medicines, today presents its financial results for the full year and net sales for the fourth quarter of 2025. FINANCIAL RESULTS FY 2025 FY 2024 change USD m USD m USD % CC %1,2 CGR %3 Net sales 11,086 10,357 7% 5% 6% Generics 7,794 7,504 4% 2% 2% Biosimilars 3,292 2,853 15% 13% 18% Core EBITDA 2,405 2,080 16% 14% Core EBITDA margin 21.7% 20.1% Core diluted earnings per share USD 3.64 USD 2.71 34% 33% Management free cash flow 1,547 1,112 39% Core return on invested capital 14.5% 12.3% Richard Saynor, Chief Executive Officer of Sandoz, said: “Our strong financial results in 2025 demonstrate the excellent headway we’re making. It was a year marked by the progress of our industry-leading pipeline, a record number of launches and significant investment in securing our biosimilars leadership for years to come. Our unrelenting focus on top-line growth, profitability and cash generation positions Sandoz well to deliver even more for patients and shareholders. “We will build on this momentum in 2026. Alongside our launch program, we plan to extend patient access, expand the pipeline and make further efficiency gains. As we cement our leadership in affordable medicines, we have an excellent platform to meet the unprecedented opportunities ahead and deliver strong results in a high-growth, attractive market.” 1 Constant currencies. 2 Non-IFRS measures are defined in the Supplementary financial information section of the Integrated Annual Report 2025. 3 Sandoz defines the comparable growth rate (CGR) as the growth rate of net sales at CC excluding the effects of material acquisitions and divestments. In the case of divestments, net sales are excluded for the corresponding period. Similarly, for acquisitions, the relevant net sales are excluded for the corresponding period. Material acquisitions and divestments are transactions in scope of significant transactions in the Company’s consolidated financial statements. Sandoz believes the presentation of CGR is meaningful for management and investors to evaluate the performance of the business over time. FINANCIAL HIGHLIGHTS FY 2025 net sales of USD 11.1 billion Up by 5% at CC and 7% in USD in the year, with volume growth of 8%; on a CGR basis, net sales grew by 6% Biosimilar sales up by 13% at CC in the year and by 18% at CGR; generics growth of 2% at CC and CGR The biosimilar share of total net sales increased to 30% (FY 2024: 28%) The 10 largest-selling medicines grew by a combined 10% at CC in the year and represented 33% of net sales In the fourth quarter, net sales of USD 3.0 billion represented growth of 6% at CC and 12% in USD; on a CGR basis, net sales grew by 7% in the quarter Core EBITDA-margin expansion in FY 2025 of 160 basis points to 21.7%, driven by a favorable mix of sales, operational efficiencies and cost discipline Core diluted earnings per share in the year up by 33% at CC to USD 3.64, mainly benefitting from growth in core net income Management free cash flow, defined as free cash flow adjusted for one-off items, amounted to USD 1.5 billion (FY 2024: USD 1.1 billion), with the increase primarily driven by the growth in core EBITDA A core return on invested capital (ROIC) of 14.5% in FY 2025 (FY 2024: 12.3%), principally a result of the strong growth in core operating income A proposed dividend per share of CHF 0.804 (FY 2024: CHF 0.60), representing 27% of core net income Full-year 2026 guidance of mid-to-high single-digit net-sales growth5 and core EBITDA-margin expansion of around 100 basis points Up by 5% at CC and 7% in USD in the year, with volume growth of 8%; on a CGR basis, net sales grew by 6% Biosimilar sales up by 13% at CC in the year and by 18% at CGR; generics growth of 2% at CC and CGR The biosimilar share of total net sales increased to 30% (FY 2024: 28%) The 10 largest-selling medicines grew by a combined 10% at CC in the year and represented 33% of net sales In the fourth quarter, net sales of USD 3.0 billion represented growth of 6% at CC and 12% in USD; on a CGR basis, net sales grew by 7% in the quarter BUSINESS HIGHLIGHTS 2025 was a milestone year for Sandoz, marked by a wave of launches across biosimilars and generics, significant progress on the transformation journey and strong financial results. The biosimilars business continued to perform strongly, supported by major launches: Pyzchiva® (ustekinumab) was launched in the US in February 2025, offering new treatment options for around 12 million patients with chronic inflammatory diseases such as psoriasis and psoriatic arthritis. The rollout included a full suite of dosing options and extended stability compared to the reference medicine The Pyzchiva autoinjector was launched in Europe in May 2025, the first ustekinumab biosimilar in Europe available in a pre-filled pen, with an improved self-administration experience supporting better treatment adherence and quality of life Wyost® & Jubbonti® (denosumab) were launched in the US in June 2025 as the first FDA6-approved interchangeable denosumab biosimilars, providing affordable treatment options for osteoporosis and cancer-related skeletal events, cementing Sandoz’s leadership in oncology and immunology biosimilars Tyruko® (natalizumab) was launched in the US in November 2025 as the first and only multiple-sclerosis biosimilar, approved for all indications of the reference medicine Afqlir® (aflibercept) was launched in Europe in November 2025, offering an affordable-treatment option for retinal diseases such as neovascular age-related macular degeneration, expanding Sandoz’s presence in the ~USD 15 billion anti-VEGF7 market Wyost & Jubbonti were launched in Europe in December 2025 In November 2025, Sandoz signed a global license agreement with EirGenix Inc. to commercialize a proposed biosimilar of pertuzumab for HER2‑positive early and metastatic breast cancer, a market worth approximately USD 4.1 billion8, strengthening the Company’s oncology portfolio and complementing its trastuzumab biosimilars. In December 2025, Sandoz completed the strategic acquisition of Just-Evotec Biologics EU SAS, including a site in Toulouse, France, expanding in-house development and manufacturing capabilities. In addition, Sandoz acquired an indefinite license to Just-Evotec Biologics, Inc.’s cutting-edge continuous-manufacturing technology. These acquisitions complemented ongoing investments in Slovenia, as Sandoz builds a vertically integrated European biosimilar development and manufacturing network. In 2025, Sandoz increased the availability of affordable medicines through several important generic launches, including rivaroxaban in Germany, expanding access to high-quality antithrombotic treatment options with multiple dosage forms. In September 2025, Sandoz launched its iron-sucrose injection in the US, broadening access to affordable treatment for iron-deficiency anemia in patients with chronic kidney disease and complementing its injectable iron-therapy portfolio. The Sandoz pipeline is industry‑leading, with 27 biosimilar assets and around 400 generics in development, targeting around USD 420 billion in originator sales. In 2025, the pipeline benefited from positive shifts in regulatory streamlining across key biosimilar programs - developments that are expected to deliver meaningful advantages for both patients and Sandoz. 4 Subject to approval at the Annual General Meeting on April 9, 2026. 5 At CC. 6 US Food & Drug Administration. 7 Vascular endothelial growth factor. 8 Evaluate Pharma, Summary: worldwide sales (last accessed November 2025). FULL-YEAR 2026 GUIDANCE Sandoz anticipates an acceleration of net-sales growth in 2026, partly reflecting the expected performance of recently launched biosimilars. This growth, alongside a favorable movement in the mix of sales, further operating efficiencies and cost discipline, is expected to result in expansion in the core EBITDA margin. As a result, the Company provides its financial guidance for 2026: Net sales to grow at CC by a mid to high single-digit percentage Core EBITDA-margin expansion of around 100 basis points Core EBITDA-margin expansion of around 100 basis points No material contribution from any potential launch of generic semaglutide is expected in 2026, while overall pricing is expected to decline by a low to mid single‑digit percentage. The guidance excludes any impacts of unforeseen events or unconfirmed developments, including the imposition of new tariffs emanating from the US government. PENICILLINS: TRADE DISTORTION As part of its vertically integrated penicillins production, the Company sells certain amounts of active pharmaceutical ingredients (APIs) to other businesses. The imposition of tariffs by the US government in 2025 led to reduced exports from China to the US, prompting Chinese suppliers to significantly lower global prices for key penicillin APIs, including 6‑Aminopenicillanic acid (6‑APA), the foundational compound for all penicillins. This price decline coincided with an increase in global market supply. These dynamics adversely impacted the Sandoz generics net-sales performance in H2 2025; a similar impact is expected in the first half of 2026. No imminent return to prior market conditions is anticipated. The recently announced introduction of a minimum import price of 6‑APA in India is expected to curb the inflow of low‑priced imports, primarily from China, and support the domestic fermentation‑based antibiotic production in India. This risks a diversion of the supply of low-cost 6-APA towards Europe, which continues to depend on Asia for key intermediates. CONFERENCE CALL A conference call and webcast for investors and analysts will begin today at 9.30am CET. Details can be found here, with the accompanying presentation here. NOTES The performance shown in this announcement covers the twelve-month period ended December 31, 2025 (FY 2025), the six-month period ended December 31, 2025 (H2 2025) and the three-month period ended December 31, 2025 (Q4 2025), compared to the twelve-month period ended December 31, 2024 (FY 2024), the six-month period ended December 31, 2024 (H2 2024) and the three-month period ended December 31, 2024 (Q4 2024), respectively. Commentary is based on the performance in FY 2025, unless stated otherwise. In this announcement, ‘Company’ refers to Sandoz Group AG. Over one billion patients were reached by Sandoz in 2025, including an estimated 0.2 billion patients reached through API sales. INTEGRATED ANNUAL REPORT Sandoz published its Integrated Annual Report 2025 today, which can be found here. CALENDAR The Company intends to publish its first-quarter sales update on April 29, 2026. CONTACTS Media Relations Investor Relations global.mediarelations@sandoz.com investor.relations@sandoz.com Alex Kalomparis+41 79 279 02 85 Craig Marks+44 7818 942 383 Gregor Rodehueser+49 170 574 3200 Tamara Hackl+41 79 790 52 17 Danja Spring+41 79 156 74 88 Silvia Siegfried+41 79 795 90 61 DISCLAIMER This media release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information section of the 2025 Integrated Annual Report. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 colleagues of 100 nationalities work together to ensure over one billion patients are reached by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 medicines addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. In 2026, Sandoz celebrates 20 years of pioneering biosimilars, 80 years of antibiotics manufacturing and 140 years of heritage. FULL-YEAR AND FOURTH-QUARTER NET SALES NET SALES BY BUSINESS FY 2025 FY 2025 % of FY 2024 change USD m net sales USD m USD % CC % CGR % Generics 7,794 70% 7,504 4% 2% 2% Biosimilars 3,292 30% 2,853 15% 13% 18% Net sales 11,086 100% 10,357 7% 5% 6% Net sales amounted to USD 11.1 billion, reflecting growth of 5% at CC and 6% at CGR. Volumes grew by 8%, partly offset by price erosion of 3%. Net-sales growth was primarily driven by the strong performance of biosimilars, which continued to benefit from an extensive pipeline and launch program. Generics overview Net sales of generics amounted to USD 7.8 billion, reflecting growth of 2% at CC and CGR. Generics represented 70% of net sales in the year (FY 2024: 72%). The increase in net sales of generics in Europe of 2% at CC and CGR was driven by the impact of launches in 2024 and 2025. International net sales of generics grew by 2% at CC and by 4% at CGR, after adjusting for the 2024 divestment of the Sandoz business in China; sales benefited from continued price increases and launches. In North America, net sales of generics were stable at CC and CGR, with the impact of strong levels of competition offset by the impact of the successful Q4 2024 US launch of paclitaxel, as well as a good performance in Canada. Biosimilars overview Net sales of biosimilars amounted to USD 3.3 billion in the year, reflecting growth of 13% at CC and 18% at CGR; biosimilars represented 30% of total net sales (FY 2024: 28%). Strong Europe biosimilars net-sales growth of 14% at CC and CGR reflected several good performances, including Pyzchiva, Binocrit® (epoetin alfa) and Hyrimoz® (adalimumab). Afqlir, Wyost & Jubbonti were launched in Europe in Q4 2025. International biosimilar net-sales growth of 30% at CC and CGR reflected strong contributions from Omnitrope® (somatropin) and Hyrimoz. Wyost & Jubbonti were launched in Q3 2025 in the International region. North America biosimilar net sales grew by 2% at CC and by 19% at CGR, with the difference reflecting the withdrawal of Cimerli® (ranibizumab) in Q1 2025. The strong underlying performance was partly a result of the successful launch of Wyost & Jubbonti in Q2 2025. Tyruko was launched in the US in Q4 2025. Q4 2025 Q4 2025 % of Q4 2024 change USD m net sales USD m USD % CC % CGR % Generics 2,095 69% 1,946 8% 2% 2% Biosimilars 934 31% 769 21% 16% 20% Net sales 3,029 100% 2,715 12% 6% 7% Net sales for the fourth quarter were USD 3.0 billion, reflecting growth of 6% at CC and 7% at CGR. Volumes grew by 9%, partly offset by price erosion of 3%. NET SALES BY REGION FY 2025 FY 2025 % of FY 2024 change USD m net sales USD m USD % CC % CGR % Europe 5,936 54% 5,363 11% 6% 6% International 2,713 24% 2,557 6% 7% 9% North America 2,437 22% 2,437 0% 0% 5% Net sales 11,086 100% 10,357 7% 5% 6% Europe overview Net sales in Europe in the year amounted to USD 5.9 billion, reflecting growth of 6% at CC and CGR. Europe net sales of generics increased by 2% at CC and CGR, with biosimilars up by 14% at CC and CGR. Notable growth included that from Pyzchiva, Binocrit and Hyrimoz. International overview Net sales in International in the year amounted to USD 2.7 billion, with growth of 7% at CC and 9% at CGR. International net sales of generics grew by 2% at CC and by 4% at CGR, with biosimilars up by 30% at CC and CGR. The performance was supported by strong sales of Omnitrope and Hyrimoz. North America overview Net sales in North America in the year amounted to USD 2.4 billion, reflecting a stable performance at CC. Growth at CGR, namely excluding the impact of the acquisition of Cimerli, amounted to 5%. Generics net sales in the year were stable at CC and CGR, with the effects of strong levels of competition offset by the impact of the successful 2024 US launch of paclitaxel, as well as a good performance in Canada. North America biosimilar net sales grew by 2% at CC and by 19% at CGR. Q4 2025 Q4 2025 % of Q4 2025 change USD m net sales USD m USD % CC % CGR % Europe 1,574 52% 1,367 15% 6% 6% International 770 25% 653 18% 14% 14% North America 685 23% 695 -1% -2% 2% Net sales 3,029 100% 2,715 12% 6% 7% The table of net sales by region and by business can be found in the Supplementary financial information. The North America performance in the fourth quarter was adversely affected by the impact of a one-time generics gross-to-net adjustment in Q4 2024. FY 2025 OPERATING RESULTS FY 2025 FY 2024 change USD m USD m USD % CC % Net sales 11,086 10,357 7% 5% Gross profit 5,284 4,926 7% 5% EBITDA 1,980 820 nm9 nm Operating income 1,425 307 nm nm Core gross profit 5,613 5,253 7% 5% Core gross profit margin (%) 50.6% 50.7% Core EBITDA 2,405 2,080 16% 14% Core EBITDA margin (%) 21.7% 20.1% Core operating income 2,094 1,821 15% 13% Core operating income margin (%) 18.9% 17.6% 9Not meaningful. Core gross profit amounted to USD 5.6 billion (FY 2024: USD 5.3 billion), resulting in a core gross-profit margin of 50.6% (FY 2024: 50.7%). A favorable mix of sales, reflecting double-digit biosimilars growth, and operational improvements were offset by the impacts of inflation on the cost of goods sold and price erosion. Core EBITDA was USD 2.4 billion (FY 2024: USD 2.1 billion), resulting in a core EBITDA margin of 21.7% (FY 2024: 20.1%). The increase in the margin was partly driven by the impacts of cost discipline on selling, general & administrative expenses and favorable other income and expenses, partly offset by growth in development & regulatory investment. EBITDA was USD 1,980 million (FY 2024: USD 820 million). Core adjustments of EBITDA in the year were USD 425 million (FY 2024: USD 1,260 million). These adjustments primarily reflected separation costs of USD 336 million, costs of the rationalization of internal manufacturing sites of USD 92 million, software-implementation cost-accounting impacts of USD 43 million and favorable effects from adjustments for legal costs of USD 58 million. FY 2025 NON-OPERATING RESULTS FY 2025 FY 2024 change USD m USD m USD % CC % Net financial result (218) (318) 31% 36% Income taxes (293) 12 nm nm Net income 914 1 nm nm Diluted earnings per share USD 2.09 USD 0.00 nm nm Core net financial result (219) (325) 33% 36% Core income taxes (286) (320) 11% 12% Core effective tax rate (%) 15.3% 21.4% Core net income 1,589 1,176 35% 33% Core diluted earnings per share USD 3.64 USD 2.71 34% 33% The core net financial result was an expense of USD 219 million (FY 2024: expense of USD 325 million). The decline reflected an improved net-currency result, as well as lower net interest expenses mainly driven by the repayment of EUR and USD term loans and local debt. The core effective tax rate was 15.3% (FY 2024: 21.4%), a reflection of changes in the mix of profit, adjustments to provisions for uncertain tax positions and the reorganization of the intellectual-property structure within the Company. Core net income of USD 1.6 billion (FY 2024: USD 1.2 billion) primarily reflected an increase in core operating income, and a decline in the core net financial result and in core income taxes. Core diluted earnings per share of USD 3.64 (FY 2024: USD 2.71) benefited from an increase in core net income. The weighted average number of shares diluted was 436.8 million as of December 31, 2025, versus 434.0 million as of December 31, 2024. CASH FLOW FY 2025 FY 2024 change USD m USD m USD m Net cash flows from operating activities 1,594 656 938 Cash flows used for capital expenditures (711) (554) (157) Other investing cash flows (9) (4) (5) Free cash flow 874 98 776 Payments for legal settlements, fees and expenses 663 29 634 Payments from restructuring provisions 128 40 88 Separation costs 336 348 (12) Separation-related capital expenditures 90 89 1 Other payments and receipts10 (544) 508 (1,052) Management free cash flow 1,547 1,112 435 Sandoz generated net cash flows from operating activities of USD 1,594 million (FY 2024: USD 656 million). This was mainly driven by an increase in operating income and stable net working-capital levels versus December 31, 2024. Cash flows used for capital expenditures were USD 711 million (FY 2024: USD 554 million), reflecting an increase in purchases of property, plant & equipment and intangible assets. This included the Company’s ongoing investments in Slovenia, namely a new biosimilar drug-substance production center in Lendava, a biosimilar-development center in Ljubljana and a new production plant in Brnik. It also included separation-related investments in facilities and technology. Free cash flow amounted to USD 874 million (FY 2024: USD 98 million). The improvement was mainly due to increased net cash flows from operating activities, partly offset by the growth in cash flows used for net capital expenditures. Management free cash flow, defined as free cash flow adjusted for one-off items, amounted to USD 1,547 million (FY 2024: USD 1,112 million). The performance was primarily a result of the growth in core EBITDA. 10 In FY 2025, other payments and receipts included the disbursements from qualified settlement funds relating to government generic-pricing antitrust investigations, antitrust class actions, opioid litigations in the US, and the payment for a technology acquisition from Just-Evotec Biologics, Inc. In FY 2024, other payments and receipts included two deposited settlement amounts of USD 233 million and USD 275 million, related to government generic-pricing antitrust investigations and antitrust class actions in the US. CAPITAL RESOURCES Dec 31 2025 Dec 31 2024 change USD m USD m USD m Inventories 2,845 2,800 45 Trade receivables 2,508 2,205 303 Trade payables (1,850) (1,519) (331) Net working capital 3,503 3,486 17 Non-current financial debts and derivative financial instruments 4,700 4,390 310 Current financial debts and derivative financial instruments 614 145 469 Total financial debts 5,314 4,535 779 Derivative financial instruments (12) (15) 3 Cash and cash equivalents (1,739) (1,191) (548) Total current financial assets (1,751) (1,206) (545) Net debt 3,563 3,329 234 Net debt to core EBITDA ratio 1.5x 1.6x Core ROIC (%) 14.5% 12.3% Net working capital remained broadly stable year‑on‑year, despite strong sales growth. Total inventories increased by USD 45 million, with lower levels of inventory more than offset by currency-translation effects. Trade receivables increased by USD 303 million, with trade payables up by USD 331 million, primarily reflecting currency-translation effects. Non-current financial debts and derivative financial instruments increased by USD 310 million, a reflection of the issuance of three bonds in the first half of 2025, totalling EUR 500 million and CHF 400 million, respectively and currency-translation effects. This was partly offset by the repayment of USD 750 million equivalent in USD and EUR term loans, as well as the reclassification of USD 504 million from non-current to current financial debts of a CHF-denominated bond, maturing in 2026. Current financial debts and derivative financial instruments increased by USD 469 million, primarily a result of the reclassification of USD 504 million from non-current to current financial debts. Cash and cash equivalents increased by USD 548 million, as cash generated from operating activities and proceeds from the issuance of non-current financial debts were partly offset by the repayment of term loans, the annual dividend payment, purchases of property, plant & equipment, purchases of intangible assets and the acquisition of Just-Evotec Biologics EU SAS. As a result, net debt increased to USD 3,563 million (December 31, 2024: USD 3,329 million), mainly driven by currency-translation effects of USD 442 million. Excluding these effects, net debt amounted to USD 3,121 million. An increase in core ROIC to 14.5% (FY 2024: 12.3%) was a result of strong growth in core operating income and a lower core effective tax rate. DIVIDEND A dividend of CHF 0.60 per share in respect of the 2024 financial year was approved by the Annual General Meeting on April 15, 2025, and paid. A dividend proposal of CHF 0.80 per share in respect of the 2025 financial year, representing 27% of core net income, is subject to approval at the Annual General Meeting on April 9, 2026. SUPPORTING FINANCIAL INFORMATION 2025 NET SALES BY BUSINESS H1 2025 change H2 2025 change FY 2025 change USD m USD % CC % USD m USD % CC % USD m USD % CC % Generics 3,736 1% 1% 4,058 7% 2% 7,794 4% 2% Biosimilars 1,496 11% 12% 1,796 19% 14% 3,292 15% 13% Net sales 5,232 4% 4% 5,854 10% 6% 11,086 7% 5% BY REGION H1 2025 change H2 2025 change FY 2025 change USD m USD % CC % USD m USD % CC % USD m USD % CC % Europe 2,832 8% 6% 3,104 14% 6% 5,936 11% 6% International 1,284 1% 5% 1,429 11% 9% 2,713 6% 7% North America 1,116 -2% -1% 1,321 2% 2% 2,437 0% 0% Net sales 5,232 4% 4% 5,854 10% 6% 11,086 7% 5% BY REGION AND BUSINESS: H2 H2 2025 H2 2024 change USD m USD m USD % CC % CGR % Europe 3,104 2,729 14% 6% 6% Generics 2,095 1,888 11% 3% 3% Biosimilars 1,009 841 20% 11% 11% International 1,429 1,288 11% 9% 9% Generics 1,135 1,058 7% 5% 5% Biosimilars 294 230 28% 30% 30% North America 1,321 1,293 2% 2% 6% Generics 828 854 -3% -3% -3% Biosimilars 493 439 12% 12% 27% Net sales 5,854 5,310 10% 6% 7% Thereof: Total generics 4,058 3,800 7% 2% 2% Total biosimilars 1,796 1,510 19% 14% 18% BY REGION AND BUSINESS: FY FY 2025 FY 2024 change USD m USD m USD % CC % CGR % Europe 5,936 5,363 11% 6% 6% Generics 4,036 3,769 7% 2% 2% Biosimilars 1,900 1,594 19% 14% 14% International 2,713 2,557 6% 7% 9% Generics 2,154 2,113 2% 2% 4% Biosimilars 559 444 26% 30% 30% North America 2,437 2,437 0% 0% 5% Generics 1,604 1,622 -1% 0% 0% Biosimilars 833 815 2% 2% 19% Net sales 11,086 10,357 7% 5% 6% Thereof: Total generics 7,794 7,504 4% 2% 2% Total biosimilars 3,292 2,853 15% 13% 18% QUARTERLY 2025 NET SALES BY BUSINESS Q1 2025 change Q2 2025 change Q3 2025 change Q4 2025 change USD m USD % CC % USD m USD % CC % USD m USD % CC % USD m USD % CC % Generics 1,809 -3% 0% 1,927 5% 2% 1,963 6% 3% 2,095 8% 2% Biosimilars 671 8% 11% 825 15% 12% 862 16% 13% 934 21% 16% Net sales 2,480 0% 3% 2,752 8% 5% 2,825 9% 6% 3,029 12% 6% BY REGION Q1 2025 change Q2 2025 change Q3 2025 change Q4 2025 change USD m USD % CC % USD m USD % CC % USD m USD % CC % USD m USD % CC % Europe 1,372 3% 7% 1,460 12% 6% 1,530 12% 6% 1,574 15% 6% International 590 -8% -2% 694 11% 11% 659 4% 4% 770 18% 14% North America 518 -1% 1% 598 -4% -3% 636 6% 7% 685 -1% -2% Net sales 2,480 0% 3% 2,752 8% 5% 2,825 9% 6% 3,029 12% 6% QUARTERLY 2024 NET SALES BY BUSINESS Q1 2024 change Q2 2024 change Q3 2024 change Q4 2024 change USD m USD % CC % USD m USD % CC % USD m USD % CC % USD m USD % CC % Generics 1,869 0% 1% 1,835 -1% 1% 1,854 3% 4% 1,946 1% 4% Biosimilars 623 21% 21% 720 35% 37% 741 36% 37% 769 23% 25% Net sales 2,492 5% 6% 2,555 7% 9% 2,595 11% 12% 2,715 7% 9% BY REGION Q1 2024 change Q2 2024 change Q3 2024 change Q4 2024 change USD m USD % CC % USD m USD % CC % USD m USD % CC % USD m USD % CC % Europe 1,326 4% 2% 1,308 2% 3% 1,362 13% 12% 1,367 7% 8% International 642 4% 12% 627 5% 9% 635 2% 8% 653 0% 6% North America 524 6% 6% 620 22% 23% 598 17% 18% 695 13% 14% Net sales 2,492 5% 6% 2,555 7% 9% 2,595 11% 12% 2,715 7% 9% FY 2025: RECONCILIATION FROM IFRS RESULTS TO CORE RESULTS (USD millions unless indicated otherwise) IFRS results Amortization of intangibleassets11 Impair-ments12 Acquisition or divest-ment of businesses and related items13 Other items14 Core results Net sales 11,086 – – – – 11,086 Other revenues 71 – – – – 71 Cost of goods sold (5,873) 214 16 – 99 (5,544) Gross profit 5,284 214 16 – 99 5,613 Selling, general and administration (2,529) – – – 67 (2,462) Development and regulatory (1,050) – 2 – 2 (1,046) Other income 353 – – (10) (200) 143 Other expense (633) – – 12 467 (154) Operating income15 1,425 214 18 2 435 2,094 Interest expense (220) – – – – (220) Other financial income and expense 2 – – – (1) 1 Income before taxes 1,207 214 18 2 434 1,875 Income taxes16 (293) (286) Net income 914 1,589 Basic earnings per share (USD) 2.12 3.68 Diluted earnings per share (USD) 2.09 3.64 11 Amortization of intangible assets: cost of goods sold includes the amortization of rights to currently marketed products and other production-related intangible assets. 12 Impairments: cost of goods sold and development and regulatory include impairment charges related to intangible assets. 13 Acquisition or divestment of businesses and related items: other income includes a release related to the China business divestment; other expense includes costs related to the Just-Evotec Biologics EU SAS acquisition. 14 Other items: cost of goods sold, other income and other expense include the Company-wide rationalization of manufacturing sites; cost of goods sold, selling general and administration, development and regulatory, other income and other expense include the separation costs related to the spin-off; cost of goods sold, selling general and administration, development and regulatory, other income and other expense include the costs related to the transformation program and other restructuring charges; other income and other expense include legal-related charges and adjustments to contingent consideration; selling, general and administration includes software implementation cost accounting impacts; other expense includes an onerous contract adjustment; other financial income and expense includes the net monetary impacts on the restatement of non-monetary items for subsidiaries in hyperinflationary economies. 15 For further breakdown of core adjustments by category, refer to table ‘Reconciliation from IFRS operating income to core net income’. 16 Taxes on the adjustments between IFRS and core results take into account, for each individual item included in the adjustment, the tax rate that will finally, be applicable to the item based on the jurisdiction where the adjustment will finally have a tax impact. Generally, this results in amortization and impairment of intangible assets and acquisition-related restructuring and integration items having a full tax impact. There is usually a tax impact on other items, although this is not always the case for items arising from legal settlements in certain jurisdictions. Due to these factors and the differing applicable tax rates in the various jurisdictions, the tax on the total adjustments of USD 668 million to arrive at the core results before tax amounts to USD -7 million. The average tax rate on the adjustments was not meaningful.

Drug ApprovalAcquisitionLicense out/inBiosimilar

11 Dec 2025

·www.sandoz.com

Sandoz signs global license agreement to commercialize breast cancer biosimilar pertuzumab

MEDIA RELEASE Agreement with EirGenix Inc. grants Sandoz exclusive rights to commercialize proposed biosimilar of pertuzumab for treatment of HER2-positive early breast cancer / metastatic breast cancer Reference medicine market worth USD 4.1 billion in global sales Pertuzumab used in combination with other therapies, highly complementary to proposed Sandoz biosimilars trastuzumab and trastuzumab deruxtecan Strengthens overall Sandoz position in oncology and reinforces ongoing commitment to expand patient access to affordable medicines and drive sustainable savings for healthcare systems Basel, November 12, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announced the signing of a global license agreement to commercialize a proposed biosimilar of oncology medicine pertuzumab. The agreement with EirGenix Inc. (EirGenix Inc., 6589.TW) is milestone-based, including an upfront payment and further potential incentives dependent upon market performance. The reference medicine market is worth an estimated USD 4.1 billion1 in global sales, and pertuzumab will join the deep Sandoz pipeline with the strategic objective to capitalize on a projected ~USD 300 billion biosimilar market opportunity over the next 10 years2. Under the terms of the agreement, Sandoz has exclusive worldwide commercial rights to a biosimilar of pertuzumab, excluding certain countries in Asia*, while EirGenix Inc. will be responsible for development, manufacturing and supply. The medicine has already completed a human pharmacokinetic similarity clinical study. Richard Saynor, CEO of Sandoz, said: “According to the latest estimates, up to 2.3 million patients worldwide are diagnosed with breast cancer each year and, of these cases, approximately 15% to 20% are HER2-positive breast cancer3. “This agreement underscores our commitment to expand patient access, as well as support healthcare systems by offering high quality and more affordable treatment options. It also enhances our biosimilar oncology portfolio and complements our pipeline, given that the combination of pertuzumab and trastuzumab represents the standard of care in this field.” The reference medicine Perjeta®** is a humanized IgG1 monoclonal antibody that is used in combination with other therapies, including trastuzumab, to treat HER2-positive early breast cancer and HER2-positive metastatic or locally recurrent unresectable breast cancer4,5. The agreement strengthens the collaboration between Sandoz and EirGenix Inc, with an existing agreement already in place for worldwide commercialization*** of the proposed biosimilar trastuzumab, in both 150 mg and 420 mg forms. Studies also show that a combination of pertuzumab and trastuzumab deruxtecan could become a new first-line standard for HER2-positive metastatic breast cancer6, with a biosimilar of trastuzumab deruxtecan currently in the Sandoz pipeline. Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably, with a leading global portfolio comprising 11 marketed biosimilars and a further 27 assets in various stages of development. The marketed biosimilar oncology portfolio includes Rixathon®, Zarzio®, Ziextenzo® and Binocrit®. Sandoz also launched Wyost®/Jubbonti® (denosumab) in the US in June 2025 and expects to launch in Europe in the fourth quarter of 2025. * Countries out of scope: Taiwan, China, Macau, Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines and Japan ** Perjeta® is a registered trademark of Roche *** Under this agreement, Sandoz holds the right to commercialize the medicine globally except in Russia, China, Taiwan, Australia, and some other Asian and South American countries DISCLAIMER This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law. REFERENCES 1 Evaluate Pharma, Summary: Worldwide Sales [Last accessed November 2025] 2 Based on March 2025 data from IPD Analytics Evaluate Pharma, covering the period 2026–2035 3 World Cancer Research Fund, ‘Breast Cancer Statistics’. Available at: Breast cancer statistics | World Cancer Research Fund [Last accessed November 2025] 4 Perjeta® Summary of Product Characteristics. Available at: Perjeta, INN-pertuzumab [Last accessed November 2025] 5 Perjeta® Prescribing Information. Available at: PERJETA [Last accessed November 2025] 6 The trial DESTINY-Breast09 showed that Enhertu® (trastuzumab deruxtecan) and pertuzumab significantly delayed cancer progression compared to the current standard of care (taxane and trastuzumab and pertuzumab) ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. CONTACTS Global Media Relations contacts Investor Relations contacts Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Alexis Kalomparis +41 792 790285 Craig Marks +44 7818 942 383 Chris Lewis+49 174 244 9501 Silvia Siegfried+41 79 795 9061 Gregor Rodehueser+49 170 574 3200 © 2026 Sandoz Group AG This site is intended for a global audience

License out/inDrug Approval

100 Deals associated with Epoetin alfa(Sandoz International GmbH)

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KEGG	Wiki	ATC	Drug Bank
D03231	-	B03XA01	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Anemia	European Union	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia	European Union	Hexal AG	27 Aug 2007
Anemia	Iceland	Hexal AG	27 Aug 2007
Anemia	Iceland	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia	Liechtenstein	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia	Liechtenstein	Hexal AG	27 Aug 2007
Anemia	Norway	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia	Norway	Hexal AG	27 Aug 2007
Anemia of renal disease	European Union	Hexal AG	27 Aug 2007
Anemia of renal disease	European Union	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia of renal disease	Iceland	Hexal AG	27 Aug 2007
Anemia of renal disease	Iceland	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia of renal disease	Liechtenstein	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
Anemia of renal disease	Liechtenstein	Hexal AG	27 Aug 2007
Anemia of renal disease	Norway	Hexal AG	27 Aug 2007
Anemia of renal disease	Norway	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
chronic renal failure anemia	European Union	Hexal AG	27 Aug 2007
chronic renal failure anemia	European Union	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007
chronic renal failure anemia	Iceland	Hexal AG	27 Aug 2007
chronic renal failure anemia	Iceland	MEDICE Arzneimittel Pütter GmbH & Co. KG	27 Aug 2007

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Kidney Failure, Chronic	Phase 3	United States	Sandoz Group AG	01 Sep 2012
Chronic Kidney Diseases	Phase 3	Bulgaria	Sandoz Group AG	01 Apr 2009
Chronic Kidney Diseases	Phase 3	France	Sandoz Group AG	01 Apr 2009
Chronic Kidney Diseases	Phase 3	Germany	Sandoz Group AG	01 Apr 2009
Chronic Kidney Diseases	Phase 3	Romania	Sandoz Group AG	01 Apr 2009
Chronic Kidney Diseases	Phase 3	Spain	Sandoz Group AG	01 Apr 2009

Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00701714 (CTgov)	Phase 3	Anemia \| Chronic Kidney Diseases	337	EPO HEXAL+HX575 (HX575, EPO HEXAL)	ftoplffwgp(xripjylbpr) = orhfzffjnw agqszlswfs (kgwjpwklss, 1.0) View more	-	05 Feb 2018
				ERYPO (ERYPO)	ftoplffwgp(xripjylbpr) = niamvcscnq agqszlswfs (kgwjpwklss, 1.2) View more
NCT01576341 (SENSE, Pubmed \| Clin Nephrol) Manual	Phase 3	Anemia \| Chronic Kidney Diseases	416	HX575 Epoetin Alfa	tnartoywhd(dvxizqbweh) = yzpmcycnld qlfqxzjpwy (izubkkjllx )	Positive	01 Oct 2017
NCT00711958 (CTgov)	Phase 3	Anemia	114	HX575, solution for injection (s.c.) (HX575 Epoetin Alfa Hexal AG)	hwwgxgkkva = tpsctfhaxi zautemizwo (cfessaeaao, sjtlgphuwe - aheyidwcjm) View more	-	02 Aug 2017
				ERYPO (ERYPO® Janssen-Cilag)	hwwgxgkkva = bvcszkiopn zautemizwo (cfessaeaao, uasdlorcky - enouwazzia) View more
NCT00666835 (CTgov)	Phase 3	Anemia	478	HX575 epoetin alfa Hexal AG (HX575 Epoetin Alfa Hexal AG)	luqruotiad(bsntriqmal) = zkrewdqdji ctsjnotihm (egqnmydhdb, 0.092) View more	-	02 Aug 2017
				ERYPO (ERYPO®, Janssen-Cilag)	luqruotiad(bsntriqmal) = wyzbgusizb ctsjnotihm (egqnmydhdb, 0.117) View more
NCT01576341 (SENSE, CTgov)	Phase 3	Anemia \| Chronic Kidney Diseases	417	HX575 (HX575)	ltthglipjq = ypbyjmanvl jruihefcun (zctpaychvi, zolaphpzns - zstqjtlpvy) View more	-	19 Jun 2017
				ESA+HX575 (HX575 - ESA Naive)	wmylktcanr(pofrjnrupx) = tabqdwjabb psuhvgjcqz (sfjopzyvij, 1.336) View more
NCT01693029 (ACCESS, CTgov)	Phase 3	Anemia \| Kidney Failure, Chronic \| Chronic Kidney Diseases	435	HX575 epoetin alfa (HX575 Epoetin Alfa)	fovblxadmt(qobyswhdwc) = btmgnnwqwz lgdgwoummy (zojfdvorud, 0.0575) View more	-	12 May 2017
				epoetin alfa (US-licensed Epoetin Alfa)	fovblxadmt(qobyswhdwc) = sxjaxuiavu lgdgwoummy (zojfdvorud, 0.0573) View more
NCT01693029 (Pubmed \| Am J Nephrol) Manual	Phase 3	Kidney Failure, Chronic	-	Epoetin Alfa+HX575	prvrrzxtzr(yvfaxvmqbw): difference = -0.093 (90% CI, -0.23 to 0.04)	Similar	01 Jan 2017
				Epoetin Alfa
MONITOR-CKD5 (ERA2016)	Not Applicable	Anemia in chronic kidney disease CKD5	2,023	Binocrit ®	phebyrfxrc(wynhrwlphl) = 140 pts (6.7%) were reported to have experienced an AE or SAE, including 16 (0.8%) stated to be related hytxwlazpj (yozlrtihoo ) View more	Positive	14 May 2016
MONITOR-CKD5 (ASN2014)	Not Applicable	Anemia in chronic kidney disease	2,087	HX575	vqdjwbangl(hlgxmhhpgr) = ghseqmhkxm kbgpvjdjcw (pqhdyfvebq ) View more	Positive	11 Nov 2014
not available (ASN2010)	Not Applicable	Chronic Kidney Diseases	1,695	HX575 (Epoetin alfa)	huebmrqvum(gamxskxtyd) = No subject developed anti-epoetin antibodies during the study yjzpnuzqsb (sxwucurdxq ) View more	Positive	16 Nov 2010

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