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# FDA Will Review Formycon’s Keytruda Biosimilar
- URL: https://www.fdaweb.com/fda-will-review-formycons-keytruda-biosimilar/
- Published: 2026-10-13T20:15:00.000Z
- Updated: 2026-10-13T21:46:44.000Z
- Author: David McFarland
- Tags: Biologics

FDA has accepted for review a Formycon/Zydus Lifesciences BLA for FYB206, a biosimilar to Merck’s blockbuster cancer drug Keytruda (pembrolizumab). A [statement](https://www.formycon.com/en/blog/press-release/formycon-and-zydus-fyb206-becomes-first-publicly-announced-keytruda-biosimilar-accepted-for-review-by-fda/?ref=fdaweb.com) says the biosimilar was developed without a comparative Phase 3 efficacy trial, following a development pathway agreed upon with FDA in early 2025\. The companies say they believe their BLA, which was submitted in the third quarter of 2026, is the first to be accepted by FDA for a Keytruda biosimilar.

The statement says the companies expect an FDA decision in the third quarter of 2027.

Pembrolizumab is described as an immune checkpoint inhibitor that binds to and blocks the PD-1 receptor and is used to treat numerous types of cancer.