An Open-label, Single-arm, Multicenter Study in Patients With Neovascular Age-related Macular Degeneration to Evaluate the Safety of SOK583A1 (40 mg/mL), a Proposed Aflibercept Biosimilar Product, Provided in a Vial Kit

This is a single-arm, open-label study where all patients will receive a single injection of SOK583A1 (40 mg/mL) provided in a vial kit at Baseline. The total study duration for the individual participant is approximately 31 days.

Start Date16 May 2022

Sponsor / Collaborator

Sandoz Group AG

NCT05161806

/ CompletedPhase 3

This was an open-label, single arm, multicenter, Phase IIIb study in subjects with (wet) nAMD, eligible for IVT aflibercept treatment.

Start Date11 Mar 2022

Sponsor / Collaborator

Sandoz Group AG

NCT04864834

/ CompletedPhase 3

A 52-week Multicenter, Randomized, Double-masked, 2-arm Parallel Study to Compare Efficacy, Safety and Immunogenicity of SOK583A1 to Eylea®, Administered Intravitreally, in Patients With Neovascular Age-related Macular Degeneration

Purpose and rationale: To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea EU as per Eylea approved treatment regimen in patients with nAMD.
The primary clinical question of interest is: Does SOK583A1 have similar efficacy as Eylea EU in terms of mean change in BCVA score in participants with nAMD who are anti-VEGF naive, without important protocol deviations and adherent to the treatment and completed the treatment to Week 8?

Start Date12 May 2021

Sponsor / Collaborator

Sandoz Group AG

100 Clinical Results associated with Aflibercept-abzv

100 Translational Medicine associated with Aflibercept-abzv

100 Patents (Medical) associated with Aflibercept-abzv

Literatures (Medical) associated with Aflibercept-abzv

01 Apr 2026·DRUGS & AGING

Anti-Vascular Endothelial Growth Factor Biosimilars for Use in the Aging Eye

Review

Author: Kuppermann, Baruch D ; Sharma, Ashish ; Sheth, Jay U

Anti-vascular endothelial growth factor (anti-VEGF) therapies have revolutionized the treatment of neovascular age-related macular degeneration (nAMD), a leading cause of vision loss, in addition to other retinal vascular diseases such as diabetic macular edema (DME), retinal vein occlusions (RVO). Biosimilars, which are nearly identical versions of original biologic drugs, offer a promising alternative to these costly treatments. Several biosimilars for anti-VEGF drugs including bevacizumab, ranibizumab, and aflibercept are in various stages of development and approval (e.g. Afilivu, Yesafili, Enzeevu, Ahzantive, AVT-06, ABP 938, and ALT L9). These biosimilars have shown comparable results in improving visual acuity and reducing retinal fluid in patients with nAMD but their adoption in clinical practice faces challenges, including regulatory hurdles, physician and patient acceptance, and the need for extensive post-marketing surveillance to monitor long-term safety and efficacy. However, as more data becomes available and biosimilars gain approval, they are expected to become an integral component in the management of nAMD. This review explores the current landscape of anti-VEGF biosimilars, their clinical efficacy, safety profiles, and the economic implications for treating the aging eye. It also addresses the challenges and future directions in the integration of biosimilars into routine ophthalmic practice.

01 Sep 2025·Clinical Drug Investigation

SDZ-AFL: An Aflibercept Biosimilar

Review

Author: Yahiya Y. Syed

SDZ-AFL (SOK583A1; Afqlir^®) is a biosimilar of the reference intravitreal aflibercept, a vascular endothelial growth factor inhibitor. SDZ-AFL has been approved in the EU for the treatment of the same indications in adults as reference aflibercept: neovascular age-related macular degeneration (nAMD), visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation. SDZ-AFL has similar physicochemical and pharmacodynamic properties to those of reference aflibercept, and pharmacokinetic similarity has been demonstrated in patients with nAMD. SDZ-AFL demonstrated clinical efficacy equivalent to that of reference aflibercept in patients with nAMD and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of SDZ-AFL were similar to those of reference aflibercept. The role of reference aflibercept in the management of neovascular retinal diseases is well established, and SDZ-AFL provides an effective biosimilar alternative for patients requiring ophthalmic aflibercept therapy.

01 Jan 2025·CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL

Development of Biosimilar Aflibercept SDZ-AFL

Review

Author: Alliger, Peter ; Wersig, Cornelia ; Allmannsberger, Lisa ; Silva, Rufino ; Heyn, Jens ; Urosevic, Dragan ; Dodeller, Francis

Purpose:

Aflibercept is a recombinant fusion protein that binds with high affinity to vascular endothelial growth factor A (VEGF-A), and other growth factors, reducing pathological neovascularization and abnormal vascular permeability. Aflibercept is approved as a first-line treatment for several retinal diseases, including neovascular age-related macular degeneration (nAMD); however, the high costs of these biologic agents can impede patient access. In 2024, Sandoz biosimilar aflibercept (SDZ-AFL; SOK583A1, Enzeevu/Afqlir) was approved by the US Food and Drug Administration and the European Medicines Agency as a biosimilar of reference aflibercept (Ref-AFL; Eylea, a trademark of Bayer AG and in the US of Regeneron Pharmaceuticals, Inc) based on a comprehensive package of data.

Methods:

This narrative review summarizes the totality of evidence demonstrating biosimilarity between SDZ-AFL and Ref-AFL, including physicochemical and biological characterization data from analytical in vitro studies, results of an ocular pharmacokinetic (PK) study in rabbits, and clinical efficacy, safety, immunogenicity, and systemic PK data from Phase III clinical studies.

Results:

Analytical evaluation demonstrated that SDZ-AFL has structural homology with Ref-AFL, including identical amino acid sequences, indistinguishable higher-order structures, and highly similar levels of structural variants. SDZ-AFL and Ref-AFL also demonstrated highly similar in vitro biologic activities, including target binding affinity, and potency in terms of neutralization of VEGF-A. In a single-dose ocular PK study in rabbits, vitreal exposure was comparable between SDZ-AFL and Ref-AFL after intravitreal administration. A 52-week Phase III clinical study (Mylight) evaluated the efficacy, safety, immunogenicity, and systemic PK of SDZ-AFL and Ref-AFL in 484 participants with nAMD. The primary endpoint was mean change from baseline to week 8 in best corrected visual acuity (BCVA): the difference between the SDZ-AFL and Ref-AFL groups in this endpoint was -0.3 letters (90% CI -1.5 to 1.0), which met predefined bioequivalence margins. Secondary efficacy endpoints, including changes from baseline in BCVA and central subfield foveal thickness over the whole 52-week study, were also similar for SDZ-AFL and Ref-AFL. Two subsequent "in-use" studies confirmed the safe use of SDZ-AFL provided in either a vial kit or a prefilled syringe.

Conclusion:

This comprehensive totality of evidence has established biosimilarity between SDZ-AFL and Ref-AFL based on comparable physicochemical and biological characteristics, as well as similarity in clinical efficacy, safety, and immunogenicity. The introduction of aflibercept biosimilars to the market is anticipated to reduce barriers to access, potentially increasing the number of appropriate patients with retinal diseases benefiting from this biologic therapy.

News (Medical) associated with Aflibercept-abzv

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

03 Apr 2026

·allsci.com

FDA approves Regeneron’s Eylea HD for extended five-month dosing interval

The US FDA approved an extended dosing interval for Eylea HD (aflibercept), allowing Regeneron Pharmaceuticals to label the 8 mg intravitreal injection for dosing intervals of up to five months in wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The company said this makes Eylea HD the first injectable anti-VEGF agent with a labelled interval of up to 20 weeks for both conditions, representing a label update to a product originally cleared by the US FDA in August 2023. The April 2026 approval specifically extends the maximum dosing interval beyond the 8-16 week range established at the time of the original approval. Under the updated label, patients with wAMD or DME who have completed one year of treatment may be eligible for the extended schedule. The formulation is a higher-concentration version of the established aflibercept molecule, delivered as an intravitreal injection, and developed in the US by Regeneron under its longstanding ophthalmic collaboration with Bayer, which retains commercialization rights outside the United States. The regulatory decision drew on 96-week data from two randomized, double-masked, non-inferiority pivotal trials: PULSAR, which enrolled patients with wAMD, and PHOTON, which enrolled patients with DME. Both studies compared aflibercept 8 mg against the established 2 mg dose of the same molecule. Published 48-week readouts, available via AllSci and PubMed, showed that visual acuity outcomes with the 8 mg formulation were non-inferior to those with the 2 mg reference dose at that timepoint. The company said the majority of patients in both trials maintained their visual and anatomic improvements when transitioned to extended dosing intervals over the full 96-week period, though the approval announcement did not disclose full 96-week efficacy tables or detailed safety breakdowns.. The approval lands in a retinal treatment field where the frequency of intravitreal injection has been a persistent clinical and practical concern. Anti-VEGF therapy transformed the management of wAMD and DME from the mid-2000s onward, converting conditions that frequently caused severe vision loss into ones where stabilization and, in many cases, functional improvement are achievable. Yet the injection burden associated with monthly or bimonthly dosing has long been identified as a factor in suboptimal real-world adherence, with patients and clinicians alike seeking regimens that reduce clinic visits without sacrificing disease control. Eylea HD joins a field that has already been moving toward extended durability as a central differentiating axis. Genentech’s faricimab (Vabysmo), approved in January 2022 for both wAMD and DME, introduced a bispecific mechanism targeting both VEGF-A and Angiopoietin-2, and carried labelling permitting up to 16-week dosing intervals from the outset of maintenance therapy. Genentech’s ranibizumab port delivery system, Susvimo, received US FDA approval for DME in February 2025, offering a surgically implanted refillable device that delivers continuous anti-VEGF exposure and requires refilling approximately every six months. The Eylea HD label update, at up to 20 weeks for eligible patients, extends the injectable interval further than any previously approved intravitreal anti-VEGF injection, as noted in the company’s announcement. The competitive context also includes an expanding biosimilar landscape for the original 2 mg aflibercept formulation, with Sandoz’s aflibercept-abzv (Enzeevu) receiving US FDA approval as an interchangeable biosimilar in August 2024. That dynamic adds complexity to Regeneron’s positioning of the higher-dose product, as cost-driven substitution of the reference 2 mg product becomes more feasible in parallel with the clinical case for the 8 mg formulation’s durability profile. Aflibercept itself is a fusion protein constructed from domains of VEGF receptor 1 and VEGF receptor 2 linked to an IgG1 Fc region, acting as a decoy receptor that sequesters VEGF-A, VEGF-B, and placental growth factor. Regeneron invented the molecule internally using its VelociSuite platform and has retained exclusive US commercialisation rights for the ophthalmic formulation throughout the product’s development history. The broader aflibercept franchise, including the original Eylea 2 mg product approved in 2011, has been one of Regeneron’s principal revenue sources for over a decade. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Drug ApprovalClinical Result

18 Mar 2026

·investors.alvotech.com

Alvotech Q4 2025 and Full Year 2025 Financial Results

REYKJAVIK, Iceland, March 18, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ US: ALVO, ICELAND: ALVO, STOCKHOLM: ALVO SDB) Financial Highlights A supplemental long‑form earnings release providing additional operational details and business update for Q4 2025 and the full year is available at: https://investors.alvotech.com/earnings-calendar The supplemental document is provided solely for reference and is not part of this SEC Form 6‑K. The Form 6‑K should not be read together with, or construed as referring to, the supplemental long‑form release. Q4 2025 Highlights Total revenues1 were $173 million, up 13% Year-on-Year (YoY) Adjusted EBITDA1 was $69 million with Gross Margin at 66% AVT05 was approved as a biosimilar to Simponi® in the UK and European Economic Area (EEA) AVT03 was approved as a biosimilar to Prolia® and Xgeva® in the EEA The EMA accepted for review a marketing application for AVT23, referencing Xolair® After the end of the quarter, Alvotech entered into supply and commercialization agreements with Sandoz, covering multiple biosimilars candidates in Canada, Australia and New Zealand FY 2025 Highlights Total revenues1 were $593 million, up 21% YoY Adjusted EBITDA1 was $137 million, up 27% YoY, with Gross Margin at 61% The cash balance on December 31, 2025, was $172 million Second biosimilar in the US, Selarsdi™ referencing Stelara® launched by commercial partner Teva Three new biosimilars were approved in multiple markets, including the UK, EEA and Japan Alvotech acquired Xbrane’s R&D organization in Sweden and Ivers-Lee Group in Switzerland The company listed its shares on Nasdaq Stockholm and raised new equity Linda Jonsdottir was appointed Chief Financial Officer, Dr. Balaji V. Prasad was appointed Chief Strategy Officer, while Joseph McClellan transitioned into the role of Chief Operating Officer and Anthony Maffia into the role of Chief Regulatory and Quality Officer ________________________________ 1 Figures are adjusted to exclude items that are not indicative of our ongoing operating performance. Please see the disclaimer on ‘Non IFRS Financial Measures’ at the end of this press release. As a foreign private issuer, Alvotech is not required to, and does not, prepare or file quarterly financial statements under IFRS or with the SEC. The financial information included in this Form 6-K reflects management’s current estimates and is presented for the purpose of providing an interim business update. Comments by Chairman of the Board and Outgoing CEO, Róbert Wessman: “Last year we continued to expand our dedicated end-to-end biosimilars platform, advancing our pipeline with the launches of three newly approved biosimilars, expanding our R&D operation and adding a centralized assembly and packaging unit through acquisitions, while also strengthening our global network through new commercial partnerships. “We now have five approved and on-market biosimilars supported by our global partners which provide Alvotech with commercial reach into 90 countries worldwide. We have an industry leading pipeline of 30 biosimilars in development and continue adding to it at an accelerated pace. “During the year we further strengthened our financial position, raising close to $300 million from capital markets to support continued investment in our development programs and manufacturing platform. We broadened our investor base through the listing of shares on Nasdaq Stockholm, providing better access to Nordic and European investors. “At the same time, we addressed the regulatory observations following the FDA inspection of our Reykjavik manufacturing facility and we implemented a comprehensive improvement program. Based on the progress made so far, we expect to resubmit the affected applications to the FDA during the second quarter of 2026. We have addressed regulatory observations before, and we know how to resolve them. Our focus has been on strengthening the operational platform so that we can continue to scale the business globally. “We have strengthened the leadership team, with Lisa Graver’s appointment as Chief Executive Officer, and all the key management of the company is now located onsite in Iceland. Lisa and I have worked together for over twenty years, and she is ideally positioned to lead the company through this next stage. She knows the company very well, having been a board member since 2022, which gives her a deep understanding of our strategy, our platform and our global partnerships. “As Executive Chairman of the Board I will continue to be actively engaged in the business, and I am looking forward working closely with Lisa and the leadership team as we continue building Alvotech into a leading biosimilars company.” Outlook for 2026 Management reaffirms its outlook for 2026. With continued focus on robust cash flow and margin expansion by delivering solid sales growth and driving operational efficiencies across the company, management anticipates total revenues in the range of $650-700 million in 2026, reflecting continued double-digit sales growth. Adjusted EBITDA is expected to increase to $180-220 million, supported by higher volumes of commercialized products and launches of newly approved products in Europe, the UK and Japan. Alvotech anticipates receiving U.S. approval by late 2026 for four Biologics License Applications from the U.S. Food and Drug Administration, with minimal impact on the topline. The lower end of the revenue range assumes no revenues from new launches into the U.S. market in 2026. Invitation to Q4 2025 and Full Year 2025 management presentation: Join us to listen to the live audio webcast at 8:00 AM EST (12:00 GMT, 13:00 CET) on Thursday, March 19, 2026. The audio webcast will be accessible via the following link: https://edge.media-server.com/mmc/p/u2p8ged8/ To participate via telephone in the Q&A session, please register using this link to obtain your PIN: https://register-conf.media-server.com/register/BI1c565f9bbee94c928c676ea73f178077 Presentation slides for the webcast and other materials are available on the company’s website: https://investors.alvotech.com/earnings-calendar For further information, please contact: Media – alvotech.media@alvotech.com Benedikt Stefansson Sarah MacLeod Investors - alvotech.ir@alvotech.com Dr. Balaji V Prasad (US) Patrik Ling (SE) Benedikt Stefansson (IS) The information was submitted for publication through the agency of the contact persons. Financial calendar: Annual or interim results will be released on the dates specified below, after the close of U.S. markets. An earnings call is held on the following day, after release of the results. Please note that all dates are subject to change. About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube. Forward Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. Non IFRS Financial Measures This Presentation may include projections of certain financial measures not presented in accordance with International Financial Reporting Standards (“IFRS”) including, but not limited to, Adjusted Revenues, EBITDA and certain ratios and other metrics derived therefrom. These non-IFRS financial measures are not measures of financial performance in accordance with IFRS and may exclude items that are significant in understanding and assessing the Company’s financial results. Therefore, these measures should not be considered in isolation or as an alternative to net income, cash flows from operations or other measures of profitability, liquidity or performance under IFRS. You should be aware that the Company’s presentation of these measures may not be comparable to similarly-titled measures used by other companies. The Company believes these non-IFRS measures of financial results provide useful information to management and investors regarding certain financial and business trends relating to the Company’s financial condition and results of operations. The Company believes that the use of these non-IFRS financial measures provide an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other similar companies, many of which present similar non-IFRS financial measures to investors. These non-IFRS financial measures are subject to inherent limitations as they reflect the exercise of judgments by management about which expense and income are excluded or included in determining these non-IFRS financial measures. Due to the high variability and difficulty in making accurate forecasts and projections of some of the information excluded from these projected measures, together with some of the excluded information not being ascertainable or accessible, the Company is unable to quantify certain amounts that would be required to be included in the most directly comparable IFRS financial measures without unreasonable effort. Consequently, no disclosure of estimated comparable IFRS measures is included and no reconciliation of the forward-looking non-IFRS financial measures is included. For the same reasons, the Company is unable to address the probable significance of the unavailable information, which could be material to future results.

Executive ChangeDrug ApprovalFinancial Statement

100 Deals associated with Aflibercept-abzv

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KEGG	Wiki	ATC	Drug Bank
-	-	L01XX44 S01LA05	-

R&D Status

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Indication	Country/Location	Organization	Date
Dystrophy, Macular	Canada	Sandoz AG	01 Oct 2025
Vision, Low	Australia	Sandoz Pty Ltd.	27 May 2025
Diabetic macular oedema	European Union	Sandoz GmbH	13 Nov 2024
Diabetic macular oedema	Iceland	Sandoz GmbH	13 Nov 2024
Diabetic macular oedema	Liechtenstein	Sandoz GmbH	13 Nov 2024
Diabetic macular oedema	Norway	Sandoz GmbH	13 Nov 2024
Myopic choroidal neovascularization	European Union	Sandoz GmbH	13 Nov 2024
Myopic choroidal neovascularization	Iceland	Sandoz GmbH	13 Nov 2024
Myopic choroidal neovascularization	Liechtenstein	Sandoz GmbH	13 Nov 2024
Myopic choroidal neovascularization	Norway	Sandoz GmbH	13 Nov 2024
Retinal vein occlusion-related macular edema	European Union	Sandoz GmbH	13 Nov 2024
Retinal vein occlusion-related macular edema	Iceland	Sandoz GmbH	13 Nov 2024
Retinal vein occlusion-related macular edema	Liechtenstein	Sandoz GmbH	13 Nov 2024
Retinal vein occlusion-related macular edema	Norway	Sandoz GmbH	13 Nov 2024
Wet age-related macular degeneration	United States	Sandoz, Inc.	09 Aug 2024

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04864834 (Mylight, Corporate Publications) Manual	Phase 3	Wet age-related macular degeneration	485	aflibercept	piazdyztbj(oaplbppmph) = The Mylight Phase III confirmatory efficacy and safety study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the biosimilar aflibercept and the reference biologic, Eylea®. iwxaawxfec (nuhosrbyjg ) Met	Positive	15 Aug 2023
				Eylea
NCT05282004 (CTgov)	Phase 3	Wet age-related macular degeneration	36	SOK583A1	lvfjxqqijo = bpyatdfmfh duyrhmuodv (iaugpiwgbs, qsfixsosqm - wkujdidwgb) View more	-	10 May 2023
NCT05161806 (CTgov)	Phase 3	Wet age-related macular degeneration	30	Prefilled Syringe (PFS)+SOK583A1 (40 mg/mL)	jltnrskrzf = tpyhkjqtfl cvohcwymbk (matchrwjpe, twwtaytpio - sofeylxyui) View more	-	18 Nov 2022
EURETINA2021	Not Applicable	-	-	Aflibercept	zfnquutigm(reycbhrljo) = goanibvdrb hwwkipyype (ggwnldmyam, 12.5) View more	-	01 Sep 2021
				Ranibizumab-PFS	arpvkhmpad(ktxrposljj) = amtcahfvdy vgrzivzoie (hojmhkknxi )
PROOF study (EURETINA2021)	Not Applicable	Wet age-related macular degeneration anti-VEGF	600	Ranibizumab	facnodbyuf(mxcxkgdavr) = logzxpowxe htdphehbnz (plcrscpaok, 20.69) View more	Positive	01 Sep 2021
				Aflibercept	facnodbyuf(mxcxkgdavr) = ifibbpkmxj htdphehbnz (plcrscpaok, 20.69) View more
OSPREY (ARVO2021)	Phase 2	Wet age-related macular degeneration	81	Brolucizumab	jxafeoogbz(whkxtpiwxb) = ngkyryzixs qoffcxezjc (ediuzslnlq ) View more	-	01 Jun 2021
				Aflibercept	siimhbyuoy(hxmehbkglk) = pxhflgmjox mqbttgrpih (spyxjcftwi ) View more
OSPREY (ARVO2020)	Phase 2	Wet age-related macular degeneration	-	Brolucizumab 6 mg	tdhcaeipvw(dxzrfkwoop) = kgcrdcotgz ecedlwfwng (upifquqkli ) View more	Positive	01 Jun 2020
				Aflibercept 2 mg	tdhcaeipvw(dxzrfkwoop) = svbsfznwjs ecedlwfwng (upifquqkli ) View more
ARVO2016	Not Applicable	Wet age-related macular degeneration	110	Ranibizumab	gzzqgtsopv(axngppncxw) = pcgvthokho jqivhtdbxt (sahqtpnegv, 258.63 - 284.95) View more	Positive	01 May 2016
				Aflibercept	gzzqgtsopv(axngppncxw) = fgzizzklzx jqivhtdbxt (sahqtpnegv, 235.03 - 257.62) View more

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