Samsung Bioepis to Regain European Commercial Rights for Byooviz and Opuviz from Biogen

Samsung Bioepis has announced a significant step in its commercialization strategy with the signing of an Asset Purchase Agreement (APA) with Biogen for the transfer of European commercial rights to two ophthalmology biosimilars: Byooviz (ranibizumab) and Opuviz (aflibercept). Both products are biosimilars referencing gold-standard treatments for serious retinal diseases.

Commercial Rights Transfer Effective January 2026

Under the agreement, Samsung Bioepis will assume full responsibility for the commercialization of Byooviz in Europe from January 2026. The financial terms of the transaction were not disclosed.

Linda Choi MacDonald, Executive Vice President and Global Head of Commercial at Samsung Bioepis, stated:

“We are pleased to announce our direct commercialization initiative for Byooviz in Europe. 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.”

About Byooviz and Opuviz

Byooviz (ranibizumab) is a biosimilar referencing Lucentis (ranibizumab). It received European Commission (EC) approval in August 2021, becoming the first ophthalmology biosimilar approved in Europe. It is indicated for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

Byooviz has been commercially available in multiple European countries since March 2023.

Opuviz (aflibercept), a biosimilar referencing Eylea (aflibercept), received European Commission (EC) approval in November 2024 and UK MHRA approval in April 2025. It is indicated for the treatment of wet age-related macular degeneration (AMD), visual impairment due to macular edema secondary to retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV).

However, Opuviz will not be launched in Europe until the expiration or revocation of relevant Eylea patents in the region.