Licenses And Certifications 14 October 2026
Zydus Gains FDA Acceptance for Keytruda Biosimilar BLA
Zydus has moved a step closer to entering the U.S. market with the FDA's acceptance of its Biologics License Application for a Keytruda biosimilar. The application, filed in Q3 2026, signals regulatory progress, while the drug remains listed in India's National Formulary, which tracks medicines not yet approved by the domestic regulator.
Zydus has received FDA acceptance of its Biologics License Application for a Keytruda biosimilar, bringing the company closer to a U.S. launch.
- BLA submitted in Q3 2026.
- Drug listed in India's National Formulary, indicating it is not yet CDSCO‑approved.
- Approval could open a major market for the Indian biotech firm.
Read the full report here.
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