Zydus & Formycon's Keytruda Biosimilar FYB206 Accepted for USFDA Review
Zydus and Formycon's proposed Keytruda biosimilar, FYB206, has been accepted for review by the USFDA. This is the first publicly announced acceptance for a Keytruda biosimilar. A decision is expected by Q3 2027. Zydus will commercialize in the US and Canada.
The potential approval of a biosimilar for Keytruda, one of the world's best-selling drugs, has a substantial impact on the oncology market, patient access to treatment, and Zydus's product portfolio in North America.
The USFDA's acceptance of the BLA for FYB206 is a significant positive development, marking a key milestone towards making a biosimilar version of a major cancer drug more accessible.
Zydus Lifesciences Limited and Formycon AG have jointly announced that the US Food and Drug Administration (USFDA) has accepted for review the Biologics License Application (BLA) for FYB206, a proposed biosimilar to Keytruda® (pembrolizumab). This marks the first publicly announced acceptance by the USFDA of a filing for a Keytruda® biosimilar. The BLA was submitted in the third quarter of 2026, and a decision is expected in the third quarter of 2027. The regulatory dossier has also been submitted to Health Canada.
FYB206 was developed without a comparative Phase III efficacy trial, following a development pathway agreed upon with the USFDA in February 2025. This approach accelerated the program and reduced development investment while maintaining rigorous scientific standards. Zydus holds exclusive commercialization rights for the United States and Canada, leveraging its extensive commercial experience in the North American market.
Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, stated that the acceptance is a significant step towards expanding access to affordable pembrolizumab therapy in the U.S. and Canada, potentially improving patient access and outcomes. Dr. Stefan Glombitza, CEO of Formycon AG, highlighted that this advancement positions them among the first to reach this stage with a biosimilar to the world's best-selling biologic medicine.
Keytruda® is a leading cancer therapy, with worldwide sales reaching USD 31.7 billion in 2025 and USD 16.40 billion in the first half of 2026. In December 2025, Formycon and Zydus entered into a licensing and supply agreement for FYB206 in the U.S. and Canada. Formycon will receive a milestone payment from Zydus upon the USFDA's acceptance of the BLA. Formycon holds the global rights and will participate in the gross profits.
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