Global Aflibercept Biosimilar Progress Signals Rising Access for Retinal Disease Care

Recent months have seen major developments in the international rollout of aflibercept biosimilars, with regulatory approvals, reimbursement milestones, and litigation settlements clearing the path for broader global access to affordable treatments for vision-threatening retinal diseases.

Recent approvals and settlements enhance global access to aflibercept biosimilars, improving treatment options for retinal diseases, like age-related macular degeneration and diabetic retinopathy. | Image credit: eevl - stock.adobe.com

United States: Sandoz Settlement Clears Path for Enzeevu

Sandoz announced a settlement with Regeneron Pharmaceuticals resolving all outstanding patent disputes over its aflibercept biosimilar, Enzeevu (aflibercept-abzv).¹ Patent infringement proceedings, initially filed in 2024 under the Biologics Price Competition and Innovation Act, centered on as many as 46 patents covering the reference product, Eylea (aflibercept), some of which extend to 2040. Under the terms of the settlement, Sandoz is permitted to launch Enzeevu in the US in the fourth quarter of 2026, or earlier under certain circumstances.

Enzeevu received FDA approval in August 2024 with indications for neovascular age-related macular degeneration (nAMD). The product was also provisionally determined to be interchangeable with Eylea, although full interchangeability status remains subject to exclusivity protections. By aligning legal resolution with regulatory approval, Sandoz is positioned to strengthen its ophthalmology biosimilars portfolio and expand patient access to cost-saving alternatives in the US.

Europe: Alteogen Secures EC Approval for Eyluxvi

In Europe, the European Commission (EC) granted marketing authorization to Alteogen for Eyluxvi (ALT-L9), a biosimilar to Eylea.² The decision followed a positive opinion issued by the Committee for Medicinal Products for Human Use in July 2025.

Eyluxvi is now approved across the European Union for multiple ophthalmic conditions, including nAMD, diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (branch or central), and myopic choroidal neovascularization. The approval was supported by results of a phase 3 clinical trial conducted in 12 countries between 2022 and 2024. The study, involving 431 patients with nAMD, confirmed therapeutic equivalence between Eyluxvi and Eylea, demonstrating similar safety and efficacy.

For Alteogen, Eyluxvi represents its second biosimilar approval, following its trastuzumab biosimilar launched in China, and the company’s first ophthalmology biosimilar developed through fully independent research and development and global clinical trials. Alteogen leadership emphasized that the approval marks a significant milestone in both regulatory experience and commitment to improving patient access to ophthalmic therapies in Europe and beyond.

The news comes as STADA Arzneimittel announced its aflibercept biosimilar Afiveg received EC marketing authorization the same week.³

Canada: Biocon Biologics Gains Ontario Reimbursement for Yesafili

In Canada, Biocon Biologics announced that its aflibercept biosimilar, Yesafili, has been added to the Ontario Drug Benefit Formulary.⁴ Ontario, Canada’s largest province, will now publicly fund Yesafili for the treatment of nAMD, DME, macular edema secondary to central or branch retinal vein occlusion, and myopic choroidal neovascularization.

Yesafili was the first aflibercept biosimilar approved by Health Canada, supported by a phase 3 study in patients with DME confirming no clinically meaningful differences from Eylea in efficacy, safety, or immunogenicity.

With retinal diseases such as wAMD affecting over 2 million Canadians, public reimbursement is expected to significantly reduce barriers to access while alleviating financial pressure on the health care system. Company leadership emphasized that the listing represents Biocon’s seventh biosimilar launch in Canada and underscores its role in building a sustainable biosimilars ecosystem across the country.

References

1. Sandoz reaches agreement with Regeneron, resolving all patent litigation related to its US aflibercept biosimilar. News release. Sandoz. September 9, 2025. Accessed September 19, 2025. https://www.sandoz.com/sandoz-reaches-agreement-with-regeneron-resolving-all-patent-litigation-related-to-its-us-aflibercept-biosimilar/

2. Alteogen receives European Commission approval for aflibercept biosimilar, Eyluxvi (ALT-L9). News release. Alteogen. September 17, 2025. Accessed September 19, 2025. https://www.yourcentralvalley.com/business/press-releases/cision/20250917CN75735/alteogen-receives-european-commission-approval-for-aflibercept-biosimilar-eyluxvi-alt-l9/

3. Jeremias S. EC approves new biosimilars for bone and eye conditions. The Center for Biosimilars^®. September 19, 2025. Accessed September 19, 2025. https://www.centerforbiosimilars.com/view/ec-approves-new-biosimilars-for-bone-and-eye-conditions

4. Biocon Biologics' Yesafili (aflibercept) now publicly funded in Ontario, Canada for the advanced treatment of patients with retinal diseases. News release. Biocon Biologics. September 18, 2025. Accessed September 19, 2025. https://finance.yahoo.com/news/biocon-biologics-yesafili-aflibercept-now-131100372.html