Zydus Lifesciences, through its subsidiary Zydus Lifesciences Global FZE, has entered an exclusive partnership with Formycon AG. The collaboration focuses on licensing and supplying FYB206, a biosimilar of Keytruda® (Pembrolizumab), in the US and Canada. Formycon will handle development and manufacturing, while Zydus will lead commercialization. The BLA submission to the USFDA is expected soon.
Strategic Collaboration
Zydus Lifesciences Global FZE, a subsidiary of Zydus Lifesciences Limited, has partnered with Formycon AG for the exclusive licensing and supply of FYB206, a biosimilar to Keytruda® (Pembrolizumab). The agreement, announced on December 9, 2025, will focus on the US and Canada markets.
Responsibilities and Development
Under the agreement, Formycon AG will be responsible for the development, registration, and manufacture of FYB206. Zydus Lifesciences Global FZE will handle the commercialization efforts in the designated territories. The Biologics License Application (BLA) is anticipated to be submitted to the USFDA shortly.
Statements from Leadership
Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, expressed enthusiasm about the partnership, highlighting Zydus’ entry into the North American biosimilar market with an immunotherapy product. He also noted how this venture complements Zydus’ proposed acquisition of Agenus Inc.’s manufacturing facilities.
Dr. Stefan Glombitza, CEO of Formycon, emphasized that FYB206 demonstrates Formycon’s expertise in biosimilar medicine development for regulated countries. He also underscored the importance of collaborating with Zydus, due to the latter’s proficiency and commercial presence.
Source: BSE
