Shots:
- The US FDA has accepted the BLA for FYB206, a biosimilar version of Keytruda (pembrolizumab), with FDA decision expected in the Q3’27. Regulatory dossier has also been submitted to Health Canada
- FYB206’sBLA acceptance has triggered a milestone payment from Zydus to Formycon, under their Dec 2025 exclusive licensing and supply agreement for the US & Canada
- FYB206 is a humanized anti-PD-1 monoclonal antibody, and in Feb 2025, Formycon agreed with the US FDA that a comparative P-III efficacy trial was not required
Ref: Zydus | Image: Zydus & Formycon | Press Release
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