Samsung Bioepis and Regeneron Settle Patent Dispute Over Eylea Biosimilar

Samsung Bioepis and Regeneron Pharmaceuticals have reached a settlement and license agreement regarding the U.S. commercialization of Opuviz (aflibercept-yszy 2 mg), an FDA-approved biosimilar to Eylea 2 mg (aflibercept). Under the terms of the agreement, Samsung Bioepis will be permitted to launch Opuviz in the United States beginning in January 2027.

The settlement marks the end of a legal battle that began in late 2023 when Regeneron filed a patent infringement complaint, alleging that Samsung infringed on 37 patents when it submitted an abbreviated Biologics License Application (aBLA) for the biosimilar. The complaint was filed months before Opuviz's FDA approval. Regeneron claimed that Samsung imported 17 shipments of its biosimilar to the United States over a nearly 18-month period from August 29, 2021, to March 28, 2023, in violation of patents relating to manufacturing methods, formulations, and the administration of aflibercept.

The alleged infringements fell under the Biologics Price Competition and Innovation Act (BPCIA), which allows for an expedited biosimilar review process, as well as the BPCIA's Notice of Commercial Marketing requirements. This notice requires biosimilar applicants to give 180 days' notice before an intended commercial launch, enabling the sponsor of the name-brand drug to seek injunctive relief to protect their patent rights.

Opuviz received FDA approval in May 2024 as one of two first-ever Eylea biosimilars in the United States for all indications except one. In Korea, the product was approved under the brand name Afilivu and was launched in May 2024.

The U.S. settlement follows a previously announced agreement that cleared the way for Opuviz's commercialization across Europe and the rest of the world. Under the terms of that earlier settlement, Opuviz launched in the U.K. in January, with plans to launch in the rest of Europe in April and the rest of the world, except Korea, in May. The other terms of both agreements remain confidential.

The Executive Vice President and Global Head of Commerce at Samsung Bioepis expressed delight in resolving all pending patent-related matters relating to the aflibercept biosimilar across the world. The company stated it is well-positioned to successfully launch its aflibercept biosimilar 2 mg in approved markets by working closely with healthcare systems, payers, and providers worldwide. The company added that together with ranibizumab, its ophthalmology portfolio will continue to increase accessibility and affordability of biologic medicines for patients living with retinal diseases across the world.

The vice president and head of U.S. commercial operations at Samsung Bioepis noted that as with ranibizumab biosimilars, aflibercept biosimilars have the potential to significantly improve accessibility and affordability for patients. As demand for treatment continues to grow, biosimilars can help manage costs with confidence without compromising on clinical standards.

Eylea, the original drug referenced by Opuviz, is indicated for ophthalmic conditions including wet age-related macular degeneration. Global sales reached around $9.7 billion in 2024, with U.S. sales accounting for roughly $6.2 billion.

Harrow, Inc. is expected to own the exclusive U.S. commercial rights for the biosimilar. The companies signed a deal in July 2025 that gave Harrow full responsibility over the U.S. commercialization of Opuviz and BYOOVIZ, Samsung's FDA-approved ranibizumab biosimilar, but only after Samsung finished transferring the rights from Biogen. Biogen acquired both biosimilars' rights in a 2019 partnership with Samsung but has since announced plans to terminate the agreement.