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Zydus & Formycon Partner for Keytruda Biosimilar in US & Canada

Formycon will develop, register, manufacture, and supply the product, while Zydus will be responsible for commercialization.

By: Rachel Klemovitch

Assistant Editor

Zydus Lifesciences Limited’s wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates, entered a strategic partnership with Formycon AG for the exclusive licensing and supply of checkpoint inhibitor FYB206, a biosimilar of Keytruda (Pembrolizumab) in the USA and Canada market.

Under the terms of this agreement, Formycon AG will develop, register, manufacture, and supply the product. At the same time, Zydus Lifesciences Global FZE, United Arab Emirates, will be responsible for the commercialization of FYB206 in the defined territories. 

The BLA application is expected to be submitted to the US FDA in the near future and aims to make immunotherapy affordable and accessible to patients in need.

Managing Director of Zydus Lifesciences Limited, Dr. Sharvil P. Patel, stated, “This venture marks Zydus’ entry into the North American biosimilar market, debuting with an immunotherapy product. This collaboration also complements Zydus’ recent proposed acquisition of Agenus Inc.’s California, USA-based manufacturing facilities, which we plan to integrate and leverage for manufacturing in the future.”

Dr. Stefan Glombitza, CEO of Formycon, stated, “FYB206, a biosimilar of Keytruda, demonstrates Formycon’s advanced expertise in developing biosimilar medicines for highly regulated countries. Partnering with Zydus, an organization recognized for its regulatory proficiency and commercial presence, enables us to deliver this important therapeutic option to the patients.”

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