NEW DELHI: Zydus Lifesciences and Formycon AG, an independent developer of biosimilars, jointly announced that the US Food and Drug Administration (USFDA) has accepted for review the biologics license application (BLA) for a proposed biosimilar to Merck’s Keytruda (pembrolizumab), a key cancer drug. Keytruda is the world’s best-selling biologic medicine with global sales at $16.4 billion for the first half this year, and over $31 billion in 2025.This could be the first publicly announced acceptance by the USFDA of the application for a Keytruda biosimilar, FYB206, according to the company.The BLA was submitted in the third quarter of 2026.Under the Biosimilar User Fee Amendments, the USFDA aims to complete its review within twelve months of submission, comprising up to 60 days for the filing review and 10 months for the substantive review. A decision could be expected in the third quarter of 2027.The regulatory dossier for FYB206 has also been submitted to Health Canada.In December 2025, Formycon and Zydus had entered into an exclusive licensing and supply agreement for FYB206 in the US and Canada. Formycon is responsible for completing development, preparing and filing the regulatory dossiers, and supplying the product, while Zydus holds exclusive commercialization rights for the US and Canada.
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Formycon holds the global rights to FYB206 and will participate in the gross profits of its commercialization partners.With the USFDA’s acceptance of the BLA for review, Formycon has reached a regulatory milestone under the agreement that entitles it to a milestone payment from Zydus, the statement adds.