Zydus Lifesciences Partners with Formycon to Launch Keytruda Biosimilar in US and Canada

Zydus Lifesciences Limited has entered a strategic licensing and supply agreement with Germany-based Formycon AG for the commercialization of FYB206, a biosimilar of Keytruda® (pembrolizumab), in the US and Canada. The deal marks Zydus’ entry into the North American biosimilars market with a high-value oncology product. Under the agreement: Formycon will develop, manufacture, and supply FYB206, with a Biologics License Application (BLA) expected to be submitted to the USFDA soon. Zydus Lifesciences Global FZE (UAE) will lead commercialization in the two markets. This collaboration aligns with Zydus’ broader strategy, including its proposed acquisition of Agenus Inc.’s California manufacturing facility, which it plans to integrate for future production. Dr. Sharvil P. Patel, Managing Director, highlighted that the partnership strengthens Zydus’ global footprint and mission to deliver affordable immunotherapy to cancer patients. Formycon’s CEO, Dr. Stefan Glombitza, emphasized the company’s proven expertise in biosimilar development and the strength of partnering with Zydus for regulatory and commercial execution in key markets. With FYB206, Zydus enters the fast-growing $20+ billion PD-1 inhibitor space, reinforcing its ambition to become a major player in global biosimilars. The move underscores its shift from generics to innovative, high-impact therapies across international markets.