Zydus Lifesciences and Germany’s Formycon AG 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 complete the development of FYB206, prepare the regulatory dossier and manufacture the biosimilar, while Zydus’s wholly owned subsidiary, Zydus Lifesciences Global FZE, will undertake its commercialisation in the defined territories. The partnership positions Zydus as a new entrant into the North American biosimilar market, debuting with an immunotherapy product.
FYB206 is nearing the end of its clinical development phase, with primary endpoint data expected in the first quarter of 2026. Once the data package is complete, Formycon will prepare and submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration with the aim of bringing the biosimilar to market and making immunotherapy more affordable and accessible to cancer patients in need.
The partnership leverages Zydus’s extensive commercial experience and strong presence in the U.S. market, which includes the promotion of more than 225 FDA-approved medicines across hospital and speciality segments. Formycon’s expertise in developing complex biosimilars for regulated markets underpins the collaboration and reflects rising industry confidence in both companies’ ability to deliver impactful oncology therapies.
Financial terms include upfront and milestone payments to Formycon 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 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 of roughly $29.5 billion in 2024, underscoring the significant demand for effective cancer immunotherapies and the substantial opportunity this biosimilar represents.
This strategic alliance marks a major step for both companies in expanding access to high-quality, more affordable cancer treatments in key Western markets and advancing biosimilar availability in oncology care.
