Business
Formycon and Zydus partner for exclusive licensing and supply agreement of FYB206, a biosimilar to Keytruda® (Pembrolizumab), in the U.S. and Canada
Licensing partner Zydus brings extensive commercial experience, marketing more than 225 FDA-approved medicines, providing a strong foundation for a successful launch of FYB206Strong early partnering interest underscores industry confidence in Formycon’s biosimilar expertise and development excellenceAgreement structure includes in total mid-teens-million-euro upfront and 2025 milestone payments, alongside additional development and regulatory milestones and a mid-double-digit-gross-profit-share
About this update from Formycon Ag
[{"type":"image","alt":"Formycon AG","displaySize":"","headline":null,"caption":"Formycon AG","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":100,"url":"https://media.zenfs.com/en/globenewswire.com/0d679f43624c8df78fd97649c39b7de5"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/pgHC9qJOgdg6C77eg0b1Fw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE0MDtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/0d679f43624c8df78fd97649c39b7de5","width":300,"height":100}},"lazy":false},{"type":"list","items":[{"val":[{"type":"text","content":"Licensing partner Zydus brings extensive commercial experience, marketing more than 225 FDA-approved medicines, providing a strong foundation for a successful launch of FYB206","length":175,"tagName":"p"}]},{"val":[{"type":"text","content":"Strong early partnering interest underscores industry confidence in Formycon’s biosimilar expertise and development excellence","length":126,"tagName":"p"}]},{"val":[{"type":"text","content":"Agreement structure includes in total mid-teens-million-euro upfront and 2025 milestone payments, alongside additional development and regulatory milestones and a mid-double-digit-gross-profit-share upon launch","length":210,"tagName":"p"}]},{"val":[{"type":"text","content":"Clinical development phase of FYB206 nearly completed; primary endpoint data expected in the first quarter of 2026","length":114,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":625,"olType":false},{"type":"text","content":"PLANEGG-MARTINSRIED, Germany and AHMEDABAD, India, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Formycon AG (FSE: FYB, “Formycon”) and Zydus Lifesciences Limited (including its subsidiaries and affiliates, “Zydus”), today jointly announced that they have entered into a strategic partnership for the exclusive licensing and supply of checkpoint inhibitor FYB206, a biosimilar of Keytruda®1 (Pembrolizumab), in the U.S. and Canada.","length":419,"tagName":"p"},{"type":"text","content":"Under the terms of this agreement, Formycon AG will finalize development, prepare and file the regulatory dossier, and supply the product, while Zydus will be responsible for the commercialization of FYB206 in the U.S. and Canada. Meanwhile, FYB206 is approaching the end of its clinical development phase, with primary endpoint data expected in the first quarter of 2026. Following completion of the da...