Biogen beefs up in biosimilars—again—with FDA nod for Samsung-partnered Lucentis copycat

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Biogen and Samsung Bioepis partnered on ophthalmology biosimilar candidates in November 2019.

Even as Biogen dominates biopharma headlines with its high-profile Aduhelm launch, the company's budding biosimilar business has been quietly building up—and now, it has another win.

Biogen and partner Samsung Bioepis scored an FDA approval for their biosimilar of Roche's blockbuster eye drug Lucentis. Their biosimilar, dubbed Byooviz, is set to debut next year under a license deal between the biosim partners and the branded drugmaker. 

Roche's Lucentis, approved in 2006 to treat wet age-related macular degeneration, delivered $1.61 billion in U.S. sales last year. Byooviz snared FDA approval in part thanks to a 705-patient phase 3 study that showed the drug's efficacy and safety matched Lucentis for up to 52 weeks.