Onco-Summaries: Daily Oncology Updates at a Glance
13/10/2026
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 the BLA for FYB206 for regulatory review
Regulatory submission has also been filed with Health Canada
FYB206 was developed under an FDA-aligned biosimilar pathway that did not require a comparative Phase III efficacy study
Formycon is responsible for development, regulatory activities, and supply; Zydus will lead commercialization in the US and Canada
FDA acceptance triggers a milestone payment from Zydus to Formycon under the licensing agreement
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