Zydus Lifesciences and Formycon Partner to Supply Keytruda® Biosimilar for Cancer Patients in US and Canada
Strategic Alliance Aims to Expand Access to Affordable Cancer Immunotherapy
Zydus Lifesciences (India) and Formycon AG (Germany) have entered into an exclusive strategic partnership to license and supply FYB206, a biosimilar version of the cancer immunotherapy drug Keytruda® (pembrolizumab), in the United States and Canada.
Under the terms of the agreement, Formycon will be responsible for completing the development of FYB206, preparing the regulatory dossier, and manufacturing the biosimilar. Zydus Lifesciences Global FZE, a wholly owned subsidiary of Zydus, will undertake the commercialization of the product in the defined territories. This partnership positions Zydus as a new entrant into the North American biosimilar market, debuting with an immunotherapy product.
FYB206 is nearing the conclusion of its clinical development phase, with primary endpoint data anticipated in the first quarter of 2026. Once the data package is finalized, Formycon will prepare and submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), with the goal of bringing the biosimilar to market and enhancing the affordability and accessibility of immunotherapy for cancer patients in need.
The collaboration capitalizes on Zydus’s extensive commercial experience and strong presence in the U.S. market, which includes the promotion of over 225 FDA-approved medicines across hospital and specialty segments. Formycon’s expertise in developing complex biosimilars for regulated markets underpins the collaboration.
Financially, Formycon will receive upfront and milestone payments in the mid-teens-million-euro range in 2025, with further payments tied to development and regulatory achievements. Upon launch, Formycon will also receive a mid-double-digit share of the gross profits generated in the U.S. and Canada.
Pembrolizumab, the reference product for FYB206, is one of the world’s top-selling oncology drugs, with global sales estimated at approximately $29.5 billion in 2024. This highlights the significant demand for effective cancer immunotherapies and the substantial opportunity this biosimilar represents.
