Samsung Bioepis has entered into a settlement and license agreement with Regeneron Pharmaceuticals regarding the commercialization of Opuviz (aflibercept-yszy), a biosimilar referencing Eylea (aflibercept) 2 mg, in the United States.

The agreement follows an earlier settlement between the companies covering Europe and the Rest of the World (RoW), resolving patent-related disputes tied to Samsung Bioepis’ aflibercept biosimilar. With the new US agreement in place, Samsung Bioepis will be permitted to launch Opuviz 2 mg in the US beginning in January 2027. Financial and other terms of the agreement were not disclosed.

OPUVIZ 2 mg received approval from the FDA in May 2024 as a biosimilar to Eylea 2 mg, a widely used biologic therapy for the treatment of various retinal diseases, including wet age-related macular degeneration (AMD) and diabetic macular edema (DME).

“With these two consecutive agreements, we are delighted to resolve all pending patent-related matters relating to our aflibercept biosimilar across the world,” said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial at Samsung Bioepis. “We are well-positioned to successfully launch our aflibercept biosimilar 2 mg in approved markets, by working closely with healthcare systems, payers, and providers worldwide.”