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

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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.

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

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