Formycon, Zydus' Keytruda Biosimilar Accepted for US FDA Review

12:45 AM EDT, 10/13/2026 (MT Newswires) -- The US Food and Drug Administration agreed to review Formycon (FYB.F) and Zydus Lifesciences' biologics license application for FYB206, a proposed biosimilar to Merck & Co.'s (6MK.F) cancer drug Keytruda. The drugmakers said Tuesday that the application is the first publicly announced FDA filing acceptance for a Keytruda biosimilar, with a regulatory decision potentially expected in the third quarter of 2027. FYB206 was developed without a comparative phase 3 efficacy trial under a development pathway agreed with the FDA in 2025. The acceptance triggers a milestone payment to German biosimilars developer Formycon under its licensing agreement with Zydus, which holds exclusive commercialization rights for the treatment in the US and Canada.