Bayer, Inc. | MedPath

Biocon Biologics Secures Settlement with Regeneron to Launch Aflibercept Biosimilar in US by 2026

a month ago

• Biocon Biologics has reached a settlement agreement with Regeneron allowing the launch of Yesafili, an interchangeable biosimilar to aflibercept, in the US by the second half of 2026 or earlier under certain circumstances. • The agreement resolves pending legal disputes, including an appeal at the US Court of Appeals for the Federal Circuit and litigation in the Northern District of West Virginia, clearing regulatory hurdles for market entry. • FDA-approved in May 2024, Yesafili will target multiple ophthalmic conditions including neovascular AMD, macular edema due to retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization.