By: IPP Bureau
Last updated : October 13, 2026 1:15 pm
Zydus holds exclusive commercialization rights for the United States and Canada and brings extensive commercial experience in the North American market for this product.
Zydus Lifesciences Limited and Formycon AG announced that the US Food and Drug Administration (USFDA) has officially accepted their Biologics License Application (BLA) for FYB206, a proposed biosimilar to Merck's block-buster cancer drug Keytruda (pembrolizumab).
This is the first publicly announced USFDA acceptance of a Keytruda biosimilar application, according to the companies. The BLA was submitted in Q3 2026, starting a standard 12-month BsUFA review process (60 days for filing and 10 months for substantive review). A regulatory decision is anticipated in Q3 2027. Concurrently, the regulatory dossier for FYB206 has been submitted to Health Canada.
Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, said: “Acceptance of the application marks a significant step toward expanding access to affordable pembrolizumab therapy in the U.S. and Canada. As demand for high-quality, accessible oncology treatments continues to rise, FYB206 has the potential to improve patient access and outcomes while strengthening our oncology biosimilars portfolio. Leveraging the biologics expertise of Formycon and our established oncology platform in North America, we remain focused on delivering meaningful value to patients.”
Dr. Stefan Glombitza, CEO of Formycon AG, said: “With the FDA’s acceptance of the FYB206 application for review, we are among the very first companies to advance a biosimilar to the world’s best-selling biologic medicine to this stage. We developed FYB206 on a path agreed with the FDA, without conducting a comparative Phase III efficacy trial. This enabled us to accelerate the program and substantially reduce development investment while maintaining the rigorous scientific standards required for biosimilar approval. With Zydus, we have a partner with strong commercial capabilities and a clear oncology strategy in the US and Canada. Together, we aim to make this important cancer therapy accessible to more patients.”
Pembrolizumab (Keytruda) is an immune checkpoint inhibitor blocking the PD-1 receptor to treat various cancers. With global sales reaching $31.7 billion in 2025 and $16.40 billion in the first half of 2026 (including the subcutaneous Keytruda Qlex formulation), it remains the world's best-selling biologic medicine. In February 2025, Formycon confirmed with the USFDA that its biosimilar candidate, FYB206, does not require a comparative Phase III efficacy trial.
In December 2025, Formycon and Zydus had entered into an exclusive licensing and supply agreement for FYB206 in the United States and Canada.
Formycon is responsible for finishing development, regulatory filing, and product supply for FYB206, while retaining its global rights and a share of gross profits from commercial partners. The USFDA’s acceptance of the drug's Biologics License Application (BLA) for review triggers a regulatory milestone payment to Formycon from Zydus, which will commercialise the product in the US and Canada pending regulatory and intellectual property clearances.