ARTICLE
29 November 2024

European Commission Approves Samsung Bioepis And Biogen's Aflibercept Biosimilar

GP
Goodwin Procter LLP

Contributor

At Goodwin, we partner with our clients to practice law with integrity, ingenuity, agility, and ambition. Our 1,600 lawyers across the United States, Europe, and Asia excel at complex transactions, high-stakes litigation and world-class advisory services in the technology, life sciences, real estate, private equity, and financial industries. Our unique combination of deep experience serving both the innovators and investors in a rapidly changing, technology-driven economy sets us apart.
On November 18, 2024, Samsung Bioepis announced that the European Commission (EC) has approved its aflibercept biosimilar, OPUVIZ.
United States Food, Drugs, Healthcare, Life Sciences

On November 18, 2024, Samsung Bioepis announced that the European Commission (EC) has approved its aflibercept biosimilar, OPUVIZ. Referencing Regeneron's biosimilar product EYLEA, OPUVIZ is a 40 mg/mL solution for injection, approved for the treatment of neovascular age related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema, and visual impairment due to myopic choroidal neovascularization. OPUVIZ was developed by Samsung Bioepis, and Biogen holds commercialization rights to the product in the United States. OPUVIZ is the second EC-approved ophthalmology biosimilar under Samsung Bioepis and Biogen's partnership.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More