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News

FDA Approves Third Lucentis® (ranibizumab) Interchangeable Biosimilar: Formycon’s Nufymco™

by Robert S. Schwartz, Ph.D.
December 20, 2025

On December 18, 2025, the FDA approved Formycon and Zydus’s Nufymco™ (ranibizumab-leyk) as the third interchangeable biosimilar of Genentech’s Lucentis® (ranibizumab).  Lucentis® biosimilars have been on the market since July 2022 and had reached over 50% market share until Q2 2025 when interchangeable Cimerli™ (ranibizumab-eqrn) commercialization was paused for financial reasons.  According to Samsung Bioepis’s most recent Q4 2025 Biosimilar Market Report, Lucentis® regained much of its market share after Cimerli™’s withdrawal and most recently comprised 90% of the market.

Novartis reported 2024 Lucentis® sales of approximately $1.044 billion USD, and Roche reported 2024 sales of approximately $180 million USD.

For more information on biosimilar aBLA filings, please visit BiologicsHQ.com.

 

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The author would like to thank April Breyer Menon for her contributions to this article.

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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