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Amgen Files BPCIA Lawsuit Against Samsung Bioepis Prolia® / Xgeva® Proposed Biosimilar SB16

by Robert S. Schwartz, Ph.D.
August 19, 2024

On August 12, 2024, Amgen filed Case No. 1:24-cv-08417 (D.N.J.) against Samsung Bioepis, alleging SB16 (denosumab), its proposed Prolia® / Xgeva® (denosumab) biosimilar, would infringe 34 of Amgen’s patents.  The patents asserted include two patents with composition claims, four patents with composition of matter claims, 30 patents with manufacturing claims, three patents with claims directed to host cells, and one patent with claims covering devices.

According to the complaint, Samsung Bioepis’s aBLA for SB16 has been accepted by the FDA on an undisclosed date.  The FDA is also currently reviewing aBLAs from Celltrion for CT-P41 (submitted in November 2023) and Fresenius Kabi for FKS518 (accepted in May 2024) (previously reported Fresenius Kabi Announces FDA Acceptance of aBLA for Prolia® / Xgeva® (denosumab) Biosimilar Candidate FKS518).  In March, the FDA approved Sandoz’s Jubbonti® / Wyost® (denosumab-bddz) as interchangeable with Prolia® and Xgeva®.  Shortly after approval, Sandoz settled its case with Amgen (Case No. 1:23-cv-02406 (D.N.J.)), with a launch date for Jubbonti® and Wyost® by May 31, 2025, or earlier under certain undisclosed circumstances (previously reported Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation).  The BPCIA litigation between Celltrion and Amgen (Case No. 1:24-cv-06497 (D.N.J.)) is ongoing (previously reported Amgen Files BPCIA Lawsuit Against Celltrion’s Proposed Prolia® / Xgeva® (Denosumab) Biosimilar CT-P41).  There have not been any patent disputes related to FKS518 to date.

U.S. sales for Prolia® were $2.7 billion and $1.5 billion for Xgeva® in 2023.

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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