Home / Health / Keytruda Biosimilar Hits US FDA Review
Keytruda Biosimilar Hits US FDA Review
13 Oct
Summary
- USFDA reviews first Keytruda biosimilar application.
- Decision on FYB206 expected in Q3 2027.
- Zydus holds US/Canada commercialization rights.
The U.S. Food and Drug Administration (USFDA) has accepted a biologics license application for FYB206, a proposed biosimilar to Merck's highly successful cancer drug Keytruda. This acceptance by the USFDA could represent the first review of a Keytruda biosimilar. The application was submitted in the third quarter of 2026, and a decision is anticipated in the third quarter of 2027.
Formycon AG, the developer, and Zydus Lifesciences, the commercialization partner, announced this regulatory milestone. Zydus will manage sales and marketing for FYB206 in the United States and Canada, based on an agreement established in December 2025. Formycon retains global rights and will benefit from commercialization profits. The company has also submitted the regulatory dossier to Health Canada.
