Stelara® Biosimilar Updates: IPR Petition Challenging U.S. Patent No. 10,961,307 Filed and SB17 Settlement and Launch Date Announced | Venable LLP
On November 22, 2023, Biocon Biologics Inc. (“Biocon”) submitted a Petition for Inter Partes Review of claims 1-34 of U.S. Patent No. 10,961,307 (“the ’307 patent”), assigned to Janssen Biotech, Inc. (“Janssen”), requesting that trial be instituted and the challenged claims cancelled. Biocon Biologics Inc. v. Janssen Biotech, Inc., IPR2023-01444. In its Petition, Biocon alleges that methods of treating ulcerative colitis (“UC”) with ustekinumab, which the ’307 patent claims, was “publicly disclosed”, and thereby anticipated, by a Janssen “Phase 3 clinical trial summary” (“Summary”) published more than a year prior to the ’307 patent’s alleged priority date, and that the claimed “clinical trial results” that are missing from the Summary are “inevitable results from known methods.” Biocon also alleges that the ’307 patent claims are obvious because “multiple sources had reported successful off-label use of ustekinumab to treat UC using the claimed method.”
Biocon has a proposed biosimilar of Stelara® (ustekinumab), Bmab 1200, that is currently in Phase 3 development (STELLAR-2 clinical trial NCT05335356). See The study, which started on June 28, 2022, is estimated to be completed by May 30, 2024.
There are currently three pending aBLAs for proposed biosimilars of Stelara®: AVT04 from Alvotech / Teva (accepted by the FDA in January 2023, complete response letter issued in October 2023); CT-P43 from Celltrion (accepted by the FDA in June 2023); and SB17 from Samsung Bioepis (aBLA filing date is undisclosed). In November 2023 Samsung Bioepis announced a settlement and license agreement with Johnson & Johnson settling all pending U.S. patent litigations between the two companies; Samsung Bioepis and Janssen (a subsidiary of Johnson & Johnson) settled IPR2023-01103 challenging the ’307 patent now challenged by Biocon in August 2023, but did not announce the timing of SB17’s potential U.S. launch. According to a November 2023 announcement, the license period for SB17 in the U.S. will begin as early as February 22, 2025, if approved. Once approved, SB17 will be commercialized in the U.S. by Sandoz.
Amgen’s Wezlana® (ustekinumab-auub) was approved by the FDA as an interchangeable of Stelara® on October 31, 2023. See “First Biosimilar and Interchangeable of Stelara® (ustekinumab) Approved in the U.S.”
Stelara® had U.S. sales of about $6.4B in 2022.
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The authors would like to thank April Breyer Menon for her contributions to this article.
