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

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.

The biosim drug is Samsung Bioepis’ fifth biosimilar to win an FDA nod after approvals for copycats to Johnson & Johnson’s Remicade, Roche’s Herceptin, Amgen’s Enbrel and AbbVie’s Humira. It’s also the first ophthalmology biosimilar to win an FDA approval industrywide.

Samsung Bioepis and Biogen struck an ophthalmology biosimilar collaboration back in 2019. Under their deal, the Massachusetts Big Biotech will handle biosimilar marketing in the U.S. The Lucentis biosimilar also scored regulatory blessings in the United Kingdom and Europe last month.

Byooviz will be an important addition to Biogen’s biosim outfit, which generated $796 million last year. The drug’s launch will come at a key time for the drugmaker as it works to gather steam with its Aduhelm rollout in Alzheimer’s disease, and as its big-selling spinal muscular atrophy drug Spinraza faces new oral competition from Roche.

Meanwhile, biosims to Regeneron’s market-leading eye drug Eylea continue to advance through development. That branded medicine generated $4.95 billion in the U.S. last year, so it’s a larger target for copycat makers. Eylea biosims could debut in 2023, analysts figure.