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FDA Approves First Interchangeable Biosimilar of Alexion’s Soliris® (eculizumab) – Amgen’s Bkemv™ (eculizumab-aeeb)

by Robert S. Schwartz, Ph.D.
May 31, 2024

On May 28, 2024, the FDA approved Amgen’s Bkemv™ (eculizumab-aeeb), the first interchangeable biosimilar of Alexion’s Soliris® (eculizumab).  Bkemv™ was approved with a skinny label for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).  In June 2020, Amgen and Alexion settled three IPRs (IPR2019-00739, IPR2019-00740, IPR2019-00741), agreeing to a non-exclusive, royalty-free license to market Bkemv™ for the PNH indication starting March 1, 2025, or earlier in certain undisclosed circumstances.  Additional terms of the settlement were not disclosed.

While the parties have settled their U.S. disputes, in March 2024, Alexion brought one of the first biosimilar disputes at the Unified Patent Court (UPC) against Amgen’s Bekemv (eculizumab-aeeb), which was approved in the E.U. in April 2023 (previously reported The First Biosimilar Disputes at the Unified Patent Court (UPC)).  This case is currently pending.

Samsung Bioepis announced the FDA acceptance of the aBLA for its proposed biosimilar SB12 (eculizumab) in July 2023.  It currently has five pending IPRs (IPR2023-00933, IPR2023-00998, IPR2023-00999, IPR2023-01069, IPR2023-01070), and a pending BPCIA litigation (1:24-cv-00005 (D. Del.)), related to its proposed biosimilar (previously reported BPCIA Complaint Against Proposed Soliris® (eculizumab) Biosimilar SB12 Filed).  On May 6, 2024, the Court denied Alexion’s motion for a preliminary injunction against SB12.  An appeal of this decision is currently pending (CAFC Appeal No 24-1829).

AstraZeneca reported Soliris® 2023 worldwide sales of $3.145 billion USD.

For more information about these and other biosimilar aBLAs and patent disputes, please visit BiologicsHQ.

 

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

    Methodology

    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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