Zydus, Formycon partner on Keytruda biosimilar for North America

Zydus Lifesciences Global FZE, a wholly owned subsidiary of Zydus Lifesciences Limited, has entered into an exclusive partnership with Formycon AG. This agreement, announced on December 9, 2025, covers the licensing and supply of FYB206, a biosimilar to Keytruda (Pembrolizumab), for the US and Canada markets. Formycon AG will be responsible for development, registration, manufacturing, and supply, while Zydus Lifesciences Global FZE will handle commercialization in these territories.

The collaboration marks Zydus’ entry into the North American biosimilar market with an immunotherapy product. The BLA application for FYB206 is anticipated to be submitted to the USFDA in the near future. This partnership aims to enhance access to affordable oncology treatments and complements Zydus' proposed acquisition of Agenus Inc.'s California manufacturing facilities.