On December 8, 2023, the PTAB instituted three of Samsung Bioepis's pending IPRs against Alexion's Soliris® (eculizumab), IPR2023-00933, IPR2023-00998, and IPR2023-00999. The challenged patents include composition of matter, formulation, and method of treatment claims. Samsung Bioepis filed two additional IPRs in June, IPR2023-01069 and IPR2023-01070, that are awaiting institution decisions. While Samsung Bioepis has not yet announced an aBLA filing for a Soliris® biosimilar in the U.S., its biosimilar candidate Epysqli" (eculizumab) was approved in the E.U. in May 2023.
Soliris® patents previously faced IPR challenges by Amgen in 2019 that resulted in settlements. To date there have not been any public announcements of aBLA filings for Soliris® biosimilars, nor have there been any BPCIA litigations related to a Soliris®biosimilar.
Soliris®'s U.S. and E.U. sales were reported to be approximately $3.2 billion USD in 2022.
The PTAB activity for EYLEA® (aflibercept) from November (see EYLEA® (aflibercept) IPR and BPCIA Litigation Updates) has continued into December, with the PTAB granting institution of Samsung Bioepis's IPR2023-01312 against Regeneron and its motion for joinder with Celltrion's IPR2023-00462 on December 8, 2023. The challenged patent, U.S. Patent No. 10,464,992 entitled "VEGF Antagonist Formulations Suitable for Intravitreal Administration," claiming a formulation of aflibercept, is also subject to a pending litigation between Samsung Bioepis and Regeneron, 1:23-cv-00094 (N.D.W. Va.).
On December 14, 2023, Celltrion filed IPR2024-00260 along with a motion for joinder with Samsung Bioepis's IPR2023-00884, which was instituted in November. This is the twenty-sixth IPR to be filed related to an EYLEA® patent. The challenged patent, U.S. Patent No. 11,253,572 entitled "Use of a VEGF Antagonist to Treat Angiogenic Eye Disorders," claiming a method of treating angiogenic eye disorders using aflibercept, is also subject to a pending litigation between Celltrion and Regeneron, 1:23-cv-00089 (N.D.W. Va.).
Both Samsung Bioepis and Celltrion have filed aBLAs for their EYLEA®biosimilar candidates SB15 and CT-P42, respectively.
EYLEA®'s U.S. sales were reported to be about $6.26 billion in 2022.
The authors would like to thank April Breyer Menon for her contributions to this article.
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