On June 11, 2024, the Court in Case No. 1:22-cv-00061 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) issued a permanent injunction against the launch of Biocon and Mylan’s Yesafili™ (aflibercept-jbvf), a recently approved interchangeable biosimilar of Regeneron’s EYLEA^® (aflibercept) (previously reported FDA Approves First Two Interchangeable EYLEA^® Biosimilars – Biocon’s Yesafili™ (aflibercept-jbvf) and Samsung Bioepis’s Opuviz™ (aflibercept-yszy)).  The permanent injunction comes after the Court’s finding in December 2023 that Yesafili™ infringed method of treatment claims 4, 7, 9, 11, 14-17 of Regeneron’s U.S. Patent No. 11,084,865 (previously reported EYLEA^® (aflibercept) and Soliris^® (eculizumab) IPR and BPCIA Litigation Updates).  In the December 2023 order, the Court also found Yesafili™ infringed claims 6 and 25 of U.S. Patent No. 11,253,572 and claims 11 and 19 of U.S. Patent No. 10,888,601, but found those claims invalid.  In March 2024, the Court granted summary judgment of noninfringement due to disclaimer of U.S. Patent Nos. 10,406,226, 10,464,992, and 10,857,205.  The case remains pending as to 18 additional asserted patents.

Numerous other EYLEA^® biosimilars are currently involved in litigations, including Samsung Bioepis’s Opuviz™ (aflibercept-yszy) (FDA-approved May 20, 2024), Formycon’s FYB203 (aBLA accepted by FDA in August 2023), Celltrion’s CT-P42 (aBLA submitted to FDA in June 2023), and Amgen’s ABP 938 (aBLA accepted by FDA in October 2023).  Preliminary injunctions are pending in each of these cases, and the launch of Opuviz™ is under a Temporary Restraining Order through June 14, 2024.

We continue to monitor these cases and will provide updates as they become available. For more information about these and other biosimilar patent disputes, please visit BiologicsHQ.

 

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The author would like to thank April Breyer Menon for her contributions to this article.