On December 12, 2024, Gedeon Richter and Hikma announced the FDA acceptance of their aBLA for RGB-14 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab). This is the eighth publicly disclosed aBLA submission for a Prolia® / Xgeva® biosimilar, including Sandoz’s Jubbonti® / Wyost® (denosumab-bddz) (approved March 5, 2024 as interchangeable), and pending aBLAs from Celltrion: CT-P41 (accepted in November 2023), Fresenius Kabi: FKS518 (accepted in May 2024), Samsung Bioepis: SB16 (undisclosed filing date prior to August 2024), Teva: TVB-009P (accepted in October 2024), Organon / Shanghai Henlius Biotech: HLX14 (accepted in October 2024), and Accord / Intas: INTP23 (undisclosed filing date prior to November 2024).
There are numerous pending BPCIA litigations related to Prolia® / Xgeva® biosimilars, including those from 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); and Accord / Intas (Case No. 5:24-cv-00642 (E.D.N.C.)) (previously reported BPCIA Lawsuit Against Accord’s Proposed Prolia® / Xgeva® Biosimilar Filed by Amgen). Amgen filed a Motion to Transfer these cases to a Multidistrict Litigation (MDL #3138) in the District of New Jersey on November 15, 2024. Briefing was completed on December 16, 2024, and a panel hearing has been set for January 30, 2025.
Sandoz settled its BPCIA litigation with Amgen in April 2024 (Case No. 1:23-cv-02406 (D.N.J.)), agreeing to a May 31, 2025 market entry date, or earlier under certain undisclosed circumstances (previously reported Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation).
Amgen reported 2023 U.S. sales for Prolia® of $2.73 billion, and $1.52 billion for Xgeva®.
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The author would like to thank April Breyer Menon for her contributions to this article.
