Zydus Life unit partners with Formycon to supply immunotherapy drug Keytruda biosimilar in US, Canada

Drug maker Zydus Lifesciences Ltd on Tuesday (December 9) said its wholly-owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates, has entered into a strategic partnership with Formycon AG for the exclusive licensing and supply of FYB206, a biosimilar of Keytruda (pembrolizumab), in the United States and Canada.

Under the terms of the agreement, Formycon AG will be responsible for the development, registration, manufacture and supply of the product. Zydus Lifesciences Global FZE, UAE,

will handle the commercialisation of FYB206 in the defined territories of the USA and Canada.

The company said the biologics licence application is expected to be submitted to the US Food and Drug Administration in the near future. The partnership is aimed at making immunotherapy affordable and accessible to patients who require treatment.

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Dr Sharvil P Patel, Managing Director of Zydus Lifesciences, said, "We are happy to collaborate with Formycon to develop and commercialise a biosimilar of Keytruda across the US and Canada. 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-based manufacturing facilities, which we plan to integrate and leverage for manufacturing in the future. By combining our expertise and resources, we aim to drive significant organisational growth and deliver maximum value to patients through expanded access to affordable oncology care."

Dr Stefan Glombitza, CEO of Formycon, said, "FYB206, a biosimilar of Keytruda, demonstrates Formycon’s advanced expertise in developing biosimilar medicines for highly regulated countries.”

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“Partnering with Zydus, an organisation recognised for its regulatory proficiency and commercial presence, enables us to deliver this important therapeutic option to the patients. This collaboration strengthens our collective commitment to expanding access to medicines," he added.

Shares of Zydus Lifesciences Ltd ended at ₹920, down by ₹4.60, or 0.50%, on the BSE today, December 9.