Samsung Bioepis to Regain European Commercial Rights for Ophthalmology Biosimilars from Biogen

Samsung Bioepis has entered into an Asset Purchase Agreement (APA) with Biogen concerning the transfer of two ophthalmology assets: Byooviz (ranibizumab) and Opuviz (aflibercept)—both biosimilars referencing leading treatments for retinal diseases—in Europe.

Under the terms of the agreement, Samsung Bioepis will assume full responsibility for the commercialization of Byooviz upon the transfer of commercial rights from Biogen, effective January 2026. Financial terms of the deal were not disclosed. 

“We are pleased to announce our direct commercialization initiative for Byooviz in Europe,” said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial at Samsung Bioepis. “We will work closely with Biogen to ensure a seamless transition and the continued delivery of services to our customers and patients in Europe. Samsung Bioepis will continue to broaden our reach to patients across Europe by reinforcing our leadership and expertise in biosimilars.”

Byooviz (ranibizumab), referencing Lucentis (ranibizumab), received European Commission (EC) approval in August 2021, marking the first ophthalmology biosimilar authorized in Europe. The product is indicated for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV). It became commercially available across several European countries beginning March 2023.

Byooviz (aflibercept), a biosimilar referencing Eylea (aflibercept), received EC approval in November 2024 and UK MHRA approval in April 2025. It is indicated for the treatment of wet AMD, visual Impairment due to macular edema secondary to RVO, diabetic macular edema (DME), and mCNV. However, the product will not launch until after the expiration or revocation of relevant Eylea patents in Europe.