FDA Approves Lupin’s Ranibizumab Biosimilar

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Lupin has secured FDA approval for RANLUSPEC, a ranibizumab biosimilar to Genentech's LUCENTIS, marking a significant development in the treatment of neovascular age-related macular degeneration and retinal vascular disorders. This approval establishes RANLUSPEC as the only interchangeable biosimilar ranibizumab available in both vials and pre-filled syringes in the United States, representing Lupin's second biosimilar to receive FDA authorization.

United States Food, Drugs, Healthcare, Life Sciences

On June 5, Lupin announced that the U.S. Food and Drug Administration (“FDA”) approved RANLUSPEC, a ranibizumab biosimilar to Genentech’s LUCENTIS®. RANLUSPEC, which received European Marketing Authorization earlier this year, is indicated for the treatment of neovascular (wet) age-related macular degeneration and other retinal vascular disorders. It is the only interchangeable biosimilar ranibizumab approved in the United States in both vials and pre-filled syringes (PFS). RANLUSPECis now the fourth FDA-approved ranibizumab biosimilar and Lupin’s second biosimilar approved in the United States.

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FDA Approves Lupin’s Ranibizumab Biosimilar

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Food, Drugs, Healthcare, Life Sciences

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United States