Soliris^® (eculizumab)

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.

EYLEA^® (aflibercept)

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.

We continue to monitor these cases 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.