European Biosimilar Updates - Formycon’s Ustekinumab and Alvotech’s Cetrolizumab Pegol

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On June 26, 2025, Formycon AG (“Formycon”) announced a distribution agreement with Teva Group subsidiary Ratiopharm GmbH (“Ratiopharm”) for the semi-exclusive commercialization of its Stelara biosimilar FYB202/Fymskina (ustekinumab) in Germany.  Under the terms of the distribution agreement, Formycon will be responsible for the manufacture and supply of FYB202/Fymskina and will receive milestone payments and a portion of the gross margin, and Ratiopharm will be responsible for commercialization.  Fomycon Chief Business Officer Nicola Mikulcik noted that Formycon is “delighted to have gained Teva/Ratiopharm as a strong second partner for the commercialization of FYB202 in our important home market Germany” and believes that the agreement with Ratiopharm “can significantly increase market coverage in Germany with this second product, FYB202/Fymskina.”  As we previously reported, in February 2023, Formycon and Fresenius Kabi entered into a global commercialization partnership for FYB202, but Formycon retained secondary commercialization rights for Germany, parts of Latin America, and the MENA region.

In other news, on July 1, 2025, Alvotech and Advanz Pharma Holdco Limited (“Advanz Pharma”) announced that they had entered into a supply and commercialization agreement for AVT10, Alvotech’s Cimzia (certolizumab pegol) biosimilar candidate.  Per Róbert Wessman, Chairman and CEO of Alvotech, “[o]ur biosimilar biosimilar candidate is the only one referencing Cimzia® that is under development globally and the reference product has carved out significant market share as treatment for chronic rheumatic diseases, especially for women of childbearing age.”  This latest agreement follows previous agreements between the companies for biosimilar candidates for more than ten reference products.  Alvotech and Advanz Pharma expect to launch their first biosimilars in Europe in Q4 2025.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Attorney Advertising.

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