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Amgen Files Fourth BPCIA Lawsuit Against Proposed Prolia® / Xgeva® Biosimilar – Fresenius Kabi’s FKS518

by Robert S. Schwartz, Ph.D.
October 10, 2024

On October 4, 2024, Amgen filed Case No. 1:24-cv-09555 (N.D. Ill.) against Fresenius Kabi, alleging FKS518 (denosumab), its proposed Prolia® / Xgeva® (denosumab) biosimilar, would infringe 33 of Amgen’s patents.  The patents asserted include two patents with composition claims, four patents with composition of matter claims, 31 patents with manufacturing claims, one patent with claims directed to host cells, and one patent with claims covering devices.

According to a press release by Fresenius Kabi, the FDA accepted its application for FKS518 in May 2024 (previously reported Fresenius Kabi Announces FDA Acceptance of aBLA for Prolia® / Xgeva® (denosumab) Biosimilar Candidate FKS518).  The FDA is also currently reviewing denosumab aBLAs from Celltrion for CT-P41 (submitted in November 2023), Samsung Bioepis for SB16 (denosumab) (submitted on an undisclosed date), and Teva for TVB-009P (accepted in October 2024).  The FDA previously approved Sandoz’s Jubbonti® / Wyost® (denosumab-bddz) as interchangeable with Prolia® and Xgeva® in March 2024.

Sandoz settled its litigation with Amgen (Case No. 1:23-cv-02406 (D.N.J.)) in April 2024, agreeing to 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).  Amgen currently has ongoing litigations with Celltrion (Case No. 1:24-cv-06497 (D.N.J.)) (previously reported Amgen Files BPCIA Lawsuit Against Celltrion’s Proposed Prolia® / Xgeva® (Denosumab) Biosimilar CT-P41) and Samsung Bioepis (Case No. 1:24-cv-08417 (D.N.J.)) (previously reported Amgen Files BPCIA Lawsuit Against Samsung Bioepis Prolia® / Xgeva® Proposed Biosimilar SB16).  The lawsuit against Fresenius Kabi is the first related to a Prolia® / Xgeva® biosimilar to be filed in Illinois.

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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