Ahmedabad: The US Food and Drug Administration (USFDA) has accepted for review a proposed biosimilar to Keytruda, a blockbuster cancer immunotherapy, developed by Germany-based Formycon and to be commercialised by Zydus Lifesciences in the US and Canada.The biosimilar, FYB206, contains pembrolizumab, which helps the immune system fight cancer by blocking the PD-1 receptor. Keytruda and its subcutaneous formulation generated $31.7 billion in global sales in 2025, according to the companies.The companies said this was, to their knowledge, the first publicly announced USFDA acceptance of an application for a proposed Keytruda biosimilar. They submitted the application in the third quarter of 2026.The USFDA aims to complete its review within 12 months of submission. A decision could come in the third quarter of 2027. Acceptance for review does not mean approval for sale.Under an agreement signed in Dec 2025, Zydus holds exclusive commercialisation rights in the US and Canada. Formycon is responsible for completing development, filing regulatory applications and supplying the product.Commercialisation will depend on regulatory approval and the resolution of applicable intellectual property issues. Formycon said it developed FYB206 without a comparative Phase III efficacy trial. The company followed a development pathway agreed upon with the USFDA in Feb 2025. The regulatory dossier has also been submitted to Health Canada.
