Samsung Bioepis (CEO Kyung-ah Kim) announced on January 4 that it has regained the European commercialization rights for its ophthalmology biosimilar Byooviz™ from marketing partner Biogen and has begun direct sales across Europe.

Byooviz is a biosimilar of Lucentis, originally developed by Genentech, and is used to treat a range of ophthalmic conditions, including wet (neovascular) age-related macular degeneration and diabetic macular edema. The product had previously been marketed in Europe by Biogen.

The move follows Samsung Bioepis’ announcement in October 2025 that it would reclaim the European rights to Byooviz. Beginning this year, the company will directly oversee its commercialization throughout the region.

Samsung Bioepis has steadily built direct commercialization capabilities in Europe since 2023, starting with Epysqli® (a Soliris biosimilar) for rare diseases, followed by Obodence® and Xbryk® (biosimilars of Prolia and Xgeva) for bone disorders. With the addition of Byooviz, the company’s directly marketed European portfolio now comprises four products.

The company said the expansion reflects the successful accumulation of commercialization expertise and underscores its strategy to broaden operations beyond development, clinical trials, and regulatory approval to include direct market execution.

Linda Choi, Executive Vice President and Head of Commercial Operations at Samsung Bioepis, said, “The launch of direct sales for Byooviz in Europe marks an important milestone in strengthening our commercialization capabilities in the region. We will continue working closely with healthcare professionals to improve patient access to biosimilar treatments.”