FDA Accepts Formycon and Zydus’ Proposed Pembrolizumab Biosimilar for Review
On October 13, 2026, Formycon and Zydus announced that the FDA accepted for review the Biologics License Application for FYB206, a proposed biosimilar to Merck’s KEYTRUDA® (pembrolizumab). This is the first publicly announced FDA acceptance of an application for a proposed KEYTRUDA® biosimilar. Formycon also submitted the regulatory dossier to Health Canada.
Formycon and FDA agreed in February 2025 that FYB206 does not require a comparative Phase III efficacy trial. The program instead included analytical and functional comparability work and the pivotal Dahlia pharmacokinetic study, which demonstrated pharmacokinetic equivalence to the reference product, according to Formycon.
Under a licensing and supply agreement announced in December 2025, Zydus holds exclusive commercialization rights for the United States and Canada, while Formycon is responsible for completing development, preparing and filing regulatory dossiers, and supplying the product. FDA acceptance also triggers a milestone payment to Formycon under the agreement.
The BLA was submitted in the third quarter of 2026, and the companies expect an FDA decision in the third quarter of 2027 based on the agency’s review timeline.
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