On January 3, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) filed a BPCIA litigation in the District of Delaware (Case No. 1-24-cv-00005 (D. Del.)) against Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) alleging infringement of six patents, U.S. Patent Nos. 9,732,149; 9,718,880; 9,725,504; 10,590,189; 10,703,809; and 9,447,176, all of which, except for U.S. Patent No. 9,447,176, were already subject to IPR Petitions filed by Samsung Bioepis, which have been instituted for trials.  See EYLEA® (aflibercept) and Soliris® (eculizumab) IPR and BPCIA Litigation Updates. The asserted patents include four claiming methods of treating atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria, one claiming pharmaceutical compositions, and one claiming an antibody.

This is the first BPCIA litigation related to a Soliris^® (eculizumab) biosimilar. Samsung Bioepis’s proposed Soliris^® biosimilar is called SB12, and according to Alexion’s Complaint, Samsung Bioepis’s aBLA was accepted for review by the FDA on or before July 7, 2023. The review is still pending.

This is the first public announcement of an aBLA filing for a Soliris^® biosimilar. Samsung Bioepis provided its 180-day Notice of Commercial Marketing to Alexion on July 7, 2023, and thus far has declined to provide its aBLA or otherwise participate in the “patent dance.”

Soliris^®’s U.S. and E.U. sales were reported to be approximately $3.2 billion USD in 2022.

We continue to monitor this case closely and will provide updates once available.

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