ARTICLE
2 April 2026

Formycon And Regeneron Settle European Aflibercept Biosimilar Litigation

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On March 19, 2026, Formycon and its license partner Klinge Biopharma announced a settlement and license agreement with Regeneron and Bayer resolving all patent disputes relating to the EU-approved AHZANTIVE and BAIAMA aflibercept biosimilars referencing EYLEA.
United States Food, Drugs, Healthcare, Life Sciences
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On March 19, 2026, Formycon and its license partner Klinge Biopharma announced a settlement and license agreement with Regeneron and Bayer resolving all patent disputes relating to the EU-approved AHZANTIVE and BAIAMA aflibercept biosimilars referencing EYLEA.  Nicola Mikulcik, Chief Business Officer of Formycon AG stated of the announcement, “The agreement for Europe and further territories is a significant milestone, as it secures timely market access for our commercialization partners.” Under the agreement, AHZANTIVE and BAIAMA may be launched in Europe and other Latin America and Asia-Pacific markets in May 2026.

As we reported last month, Formycon is partnering with Lotus Pharmaceutical to commercialize AHZANTIVE in the Asia-Pacific Region.  Formycon previously settled its U.S. aflibercept litigation with Regeneron, securing Formycon a Q4 2026 launch date of AHZANTIVE in the United States.

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