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News

Soliris® (eculizumab) Interchangeable Biosimilar Launches: Bkemv™ and Epysqli®

by Robert S. Schwartz, Ph.D.
April 10, 2025

On April 7, 2025, Samsung Bioepis and Teva announced the launch of Epysqli® (eculizumab-aagh), a provisionally interchangeable biosimilar of Alexion / AstraZeneca’s Soliris® (eculizumab), at a 30% discount to Soliris®’s wholesale acquisition cost.  In March, Amgen launched its interchangeable biosimilar Bkemv™ (eculizumab-aeeb) at approximately a 10% discount.  These are the first Soliris® biosimilars to launch in the U.S.  Both companies launched their biosimilars pursuant to settlement agreements (see Alexion and Samsung Bioepis Settle Soliris® Biosimilar Patent Proceedings for Epysqli®).

There have not been any other publicly announced aBLAs for additional Soliris® biosimilars, and there are no ongoing patent proceedings.

AstraZeneca reported Soliris® U.S. sales of $1.523B USD in FY24.

For more information about these and other biosimilars and biosimilar patent proceedings, 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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