Licenses And Certifications 14 October 2026
Zydus' Keytruda Biosimilar Gains FDA Review Acceptance
India’s Zydus Candle has secured FDA acceptance to review its biosimilar of Merck’s Keytruda, paving the way for U.S. market entry. The move backs oncology expansion and stems from a licensing deal that gives it exclusive U.S. rights to a Chinese‑derived biosimilar.
Zydus Candle’s biosimilar of Merck’s Keytruda has been accepted by the FDA for review, marking a critical step toward a U.S. launch. The filing builds on a licensing agreement that grants Zydus exclusive U.S. rights to a Chinese‑derived biosimilar candidate.
- FDA review acceptance signals regulatory progress.
- Enables Zydus to expand its oncology portfolio.
- Leverages exclusive rights from a China‑India partnership.
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