Denosumab-dssb

OPUVIZ™ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept), will be rolled out across Europe, starting today Launch strengthens Samsung Bioepis ophthalmology portfolio in Europe, after the company began direct commercialization of BYOOVIZ ™ (ranibizumab) 10 mg/mL solution for injection in a vial in January 2026 Marks fifth biosimilar product to be directly commercialized by Samsung Bioepis in Europe OPUVIZ 40 mg/mL solution for injection in pre-filled syringe has obtained positive opinion from the Committee for Medicinal Products for Human use (CHMP) in November 2025, and is expected to be available in the market in the third quarter of this year INCHEON, Korea--(BUSINESS WIRE)-- #Europe --Samsung Bioepis Co., Ltd. today announced the launch of OPUVIZ ™ 40 mg/mL solution for injection in a vial , a biosimilar referencing Eylea 1 (aflibercept), across Europe, starting today. OPUVIZ marks the fifth biosimilar product to be directly commercialized by Samsung Bioepis. It builds on other key biosimilar milestones in Europe this year, including the initiation of direct commercialization of BYOOVIZ™ (ranibizumab) 10 mg/mL solution for injection in a vial, as well as the launch of XBRYK™ (denosumab) 120 mg solution for injection in a vial in January. “We are pleased to launch OPUVIZ in Europe, marking a significant milestone in expanding patient access to ophthalmology treatments,” said Antonio Rito, Vice President and Head of Europe, at Samsung Bioepis. “Leveraging our direct commercialization capabilities, we will work closely with healthcare professionals and payers to facilitate access to this important medicine, so that patients can benefit from quality-assured, safe and effective biosimilar alternatives.” In January 2026, Samsung Bioepis announced that the company signed a settlement and license agreement with Regeneron and Bayer concerning the commercialization of its biosimilar to Eylea 2 mg (aflibercept 40 mg/mL solution) in Europe and the Rest of the World (RoW). 2 Samsung Bioepis’s aflibercept biosimilar is also available in the Republic of Korea under the brand name AFILIVU™. About OPUVIZ OPUVIZ contains the active ingredient (aflibercept), a vascular endothelial growth factor (VEGF) inhibitor, acting as a recombinant fusion protein designed to block abnormal blood vessel growth and leakage in the eye. OPUVIZ was first approved as 40 mg/mL solution for injection in a vial by the European Commission (EC) in November 2024 and by the Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025 for adults for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV). 3,4 OPUVIZ 40 mg/mL solution for injection in pre-filled syringe has later obtained positive opinion from the CHMP in November 2025 for the same indications as the vial presentation. OPUVIZ SELECT IMPORTANT SAFETY INFORMATION The safety of OPUVIZ has been evaluated and, on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine, Eylea. For the complete list of side effects and restrictions of OPUVIZ, see the package leaflet. The most common side effects with OPUVIZ are conjunctival haemorrhage, retinal haemorrhage, reduced vision and eye pain. Other common side effects are vitreous detachment, cataract, vitreous floaters and increased intraocular pressure. Serious injection-related side effects are blindness, endophthalmitis, cataracts, increased intraocular pressure, vitreous haemorrhage and vitreous or retinal detachment. OPUVIZ must not be used in patients who have or are thought to have ocular or periocular infections, or in patients who have severe inflammation inside the eye. BYOOVIZ SELECT IMPORTANT SAFETY INFORMATION The safety of BYOOVIZ has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Lucentis. The most common side effects with ranibizumab are increased intraocular pressure, headache, vitritis, vitreous detachment, retinal haemorrhage, visual disturbance, eye pain, vitreous floaters, conjunctival haemorrhage, eye irritation, sensation of a foreign body in the eye, increased lacrimation, blepharitis, dry eye, ocular hyperaemia, eye pruritis, arthralgia and nasopharyngitis. Rarely, endophthalmitis, blindness, serious damage to the retina and cataract can occur. BYOOVIZ must not be used in patients who may have an infection of the eye or of the area around the eye, or who have severe inflammation within the eye. For the full list of side effects and restrictions of BYOOVIZ, see the package leaflet. XBRYK SELECT IMPORTANT SAFETY INFORMATION The safety of denosumab in XBRYK has been evaluated and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine, Xgeva. For the complete list of side effects and restrictions with XBRYK, see the package leaflet. The most common side effects with XBRYK include hypocalcaemia, pain in the muscles and bones, dyspnoea and diarrhoea. Other common side effects are development of another form of cancer in patients with advanced cancer, hypophosphataemia, excessive sweating, tooth loss and osteonecrosis in the jaw. Hypocalcaemia mostly occurs within the first 2 weeks of starting treatment and can be severe; however, it can be managed with calcium and vitamin D supplementation. XBRYK must not be used in patients with wounds from dental or mouth surgery that have not yet healed, or in people with severe, untreated hypocalcaemia. DISCLAIMER This press release is intended solely for the purpose of sharing the availability of OPUVIZ in Europe. This document should not be construed as medical advice or as an endorsement of any product or treatment. Regulatory approval status and prescribing information may vary by country; please refer to local product information for any medicinal products mentioned herein. Information in this press release may include data on investigational compounds or unapproved indications. Such information is shared for scientific discussion purposes only and does not represent an assertion of safety or efficacy for any unapproved use. This press release may contain forward-looking statements, including statements regarding clinical development programs, regulatory submissions, potential approvals, and future therapeutic potential. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. Forward-looking statements are not guarantees of future performance. Samsung Bioepis undertakes no obligation to update any forward-looking statements contained in this press release. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . 1 Eylea is a trademark of Regeneron Pharmaceuticals. 2 Samsung Bioepis. “Samsung Bioepis Reaches Settlement Agreement for Eylea (Aflibercept) Biosimilar in Europe and the Rest of the World.” News Release, January 30, 2026. Available at: 3 OPUVIZ EMA Summary of Product Characteristics (SmPC). Available at: (Accessed May 2026) 4 OPUVIZ MHRA Summary of Product Characteristics (SmPC). Available at: (Accessed May 2026) Contacts MEDIA CONTACT Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com

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