13/10/2026 US FDA accepts FYB206 for review as proposed Keytruda Biosimilar US FDA accepts FYB206 for review as proposed Keytruda Biosimilar (Ref) FYB206, a proposed biosimilar to Keytruda® (pembrolizumab), has been accepted for review by the US FDA, representing the first publicly announced FDA acceptance of a Keytruda biosimilar application The application was submitted by Formycon, with Zydus holding exclusive commercialization rights in the US and Canada US FDA accepted t