Zydus Partners with Formycon for Biosimilar Keytruda in North America
Filing Summary
Zydus Lifesciences Ltd, through its subsidiary Zydus Lifesciences Global FZE, has formed an exclusive partnership with Formycon AG for the licensing and supply of FYB206, a biosimilar to Keytruda (Pembrolizumab), in the US and Canada. Formycon will handle development, registration, manufacturing, and supply, while Zydus will manage commercialization. The Biologics License Application (BLA) submission to the USFDA is anticipated soon. This partnership marks Zydus’ entry into the North American biosimilar market, aligning with its strategic expansion in the region.
Zydus Lifesciences Ltd, through its wholly owned subsidiary Zydus Lifesciences Global FZE, has entered into an exclusive partnership with Formycon AG for the licensing and supply of FYB206, a biosimilar to Keytruda (Pembrolizumab), in the United States and Canada. Under this agreement, Formycon will develop, register, manufacture, and supply the biosimilar, while Zydus will be responsible for its commercialization in the specified territories.
The financial terms of the agreement between Zydus and Formycon have not been disclosed in the filing. The partnership involves the exclusive licensing rights for the biosimilar, which suggests a strategic financial arrangement to facilitate the entry of FYB206 into the North American market. The agreement is structured to leverage Formycon’s capabilities in biosimilar development and Zydus’ commercial expertise in the pharmaceutical sector.
The operational scope of this partnership includes the development, registration, and manufacturing of the biosimilar by Formycon. Zydus will handle the commercialization aspect, focusing on market entry and distribution within the US and Canada. The Biologics License Application (BLA) for FYB206 is expected to be submitted to the USFDA shortly, indicating a forthcoming regulatory milestone. This collaboration aims to make immunotherapy more accessible and affordable in these markets.
The partnership aligns with Zydus’ strategic initiatives to expand its presence in the North American biosimilar market. This move complements Zydus’ recent proposed acquisition of Agenus Inc.’s manufacturing facilities in California, which is intended to enhance its manufacturing capabilities. The collaboration with Formycon is part of Zydus’ broader strategy to integrate and leverage these facilities for future manufacturing needs.
The timeline for the BLA submission is indicated as imminent, with no specific dates provided in the filing. The partnership involves Zydus Lifesciences Global FZE and Formycon AG, with both entities playing distinct roles in the development and commercialization process. The filing does not specify further implementation dates or milestones beyond the anticipated regulatory submission.
Formycon AG is a developer of high-quality biosimilars, focusing on therapies in ophthalmology, immunology, and immuno-oncology. The company covers the entire value chain from technical development to regulatory approval. Formycon’s existing biosimilars include FYB201/ranibizumab and FYB202/ustekinumab, with additional candidates in development.
Zydus Lifesciences Ltd is an innovation-led life-sciences company with a global presence in pharmaceuticals and consumer wellness. The company is focused on expanding its footprint in the North American market through strategic partnerships and acquisitions. Zydus aims to enhance its capabilities in biosimilars and immunotherapy, aligning with its mission to provide quality healthcare solutions.