USFDA Accepts Biosimilar Application for Keytruda® Review
1 report, 1 independent
Updated 00:00
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What happened
Zydus Lifesciences Limited and Formycon AG announced that the USFDA accepted the Biologics License Application (BLA) for FYB206, a proposed biosimilar to Keytruda®. This is the first publicly announced acceptance of a Keytruda biosimilar by the USFDA. The BLA was submitted in the third quarter of 2026, and the USFDA aims to complete its review within twelve months of submission.
From prnewswire.com
Why it matters
The acceptance of the BLA initiates the regulatory process for a biosimilar to Keytruda®. Zydus holds exclusive commercialization rights for the United States and Canada for this product. The review process determines market entry for the biosimilar in the United States.
From prnewswire.com
Who's involved
- FDARegulatory agency that accepted the Biologics License Application for review.
- United States of AmericaThe country where the biosimilar application was filed.
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The entities involved
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