Zydus Lifesciences signs licensing deal with Formycon

Zydus Lifesciences, through its subsidiaries and affiliates, announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates, has entered a strategic partnership with Formycon AG for the exclusive licensing and supply of FYB206, a biosimilar of Keytruda (Pembrolizumab), for the USA and Canada markets.

Under the agreement, Formycon AG will develop, register, manufacture and supply FYB206. Zydus Lifesciences Global FZE, United Arab Emirates, will handle the commercialisation of the product within the defined territories. The BLA application is expected to be submitted to the USFDA in the near future. The partnership aims to make immunotherapy affordable and accessible to patients.

Commenting on the partnership, Dr Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, stated, “We are happy to collaborate with Formycon to develop and commercialise 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 organisational 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.”