On November 13, 2024, Amgen filed Case No. 5:24-cv-00642 (E.D.N.C.) against Accord BioPharma and Intas Pharmaceuticals, alleging INTP23, their proposed Prolia^® / Xgeva^® (denosumab) biosimilar, would infringe 34 of Amgen’s patents.  The patents asserted include two with composition claims, four with composition of matter claims, 32 with manufacturing claims, and one with claims directed to host cells.

According to the Complaint, the FDA has accepted an aBLA from Accord, but the acceptance date has not been disclosed.  This aBLA joins numerous other pending aBLAs for proposed Prolia^® / Xgeva^® biosimilars, including Celltrion’s CT-P41 (submitted in November 2023), Fresenius Kabi’s FKS518 (accepted in May 2024), Samsung Bioepis’s SB16 (submitted on an undisclosed date), Teva’s TVB-009P (accepted in October 2024), and Organon / Shanghai Henlius Biotech’s HLX14 (accepted in October 2024).  The FDA previously approved Sandoz’s Jubbonti^® / Wyost^® (denosumab-bddz) as interchangeable with Prolia^® and Xgeva^® in March 2024.

The Accord litigation is the fifth Amgen filed against a proposed Prolia^® / Xgeva^® biosimilar and includes two manufacturing patents not previously asserted (U.S. Patent Nos. 7,662,930 and 9,388,447).  While 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), the other litigations remain ongoing: 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); 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); Fresenius Kabi (Case No. 1:24-cv-09555 (N.D. Ill.)) (previously reported Amgen Files Fourth BPCIA Lawsuit Against Proposed Prolia^® / Xgeva^® Biosimilar – Fresenius Kabi’s FKS518).  The lawsuit against Accord is the first related to a Prolia^® / Xgeva^® biosimilar filed in the Eastern District of North Carolina.

Amgen reported 2023 U.S. sales for Prolia^® of  $2.73 billion, and $1.52 billion for Xgeva^®.

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.