Zydus and Formycon Report the US FDA BLA Acceptance for FYB206 (Biosimilar, Keytruda)

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 PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post Zydus and Formycon Report the US FDA BLA Acceptance for FYB206 (Biosimilar, Keytruda) appeared first on PharmaShots.