Under the terms of this agreement, Formycon AG will develop, register, manufacture and supply the product, while 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 USFDA in the near future.
Commenting on this strategic partnership, Managing Director of Zydus Lifesciences Limited, Dr. Sharvil P. Patel stated, “We are happy to collaborate with Formycon to develop and commercialize a biosimilar of Keytruda across 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, USA 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 organizational growth and deliver maximum value to patients through expanded access to affordable oncology care.”
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. This collaboration strengthens our collective commitment to expanding access to medicines.”
Read also: Zydus scores tentative USFDA nod for Empagliflozin, Linagliptin Tablets for diabetes
Zydus Lifesciences Ltd. is a global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Over the last decade, Zydus has introduced several products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and New Chemical Entities.
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