Licenses And Certifications 13 October 2026
Zydus and Formycon Secure USFDA Review for Keytruda Biosimilar
Zydus and Formycon have secured USFDA acceptance to review their Biologics License Application for FYB206, a biosimilar to Merck’s Keytruda cancer drug. The decision moves the candidate nearer a U.S. launch, with regulators set to assess safety and similarity to enable a cheaper immunotherapy.
USFDA Review Acceptance
- Zydus and Formycon’s FYB206 biosimilar to Keytruda received BLA review acceptance.
- The move advances the product toward potential U.S. market entry.
- Regulators will evaluate safety, efficacy and manufacturing similarity to determine if FYB206 can provide a lower‑cost cancer immunotherapy.
For full details, see the Free Press Journal article.
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