On October 30, 2024, Organon announced the FDA acceptance of its aBLA for HLX14, a proposed biosimilar of Amgen's Prolia® / Xgeva® (denosumab). Organon licensed the commercialization rights for HLX14 in the U.S. from Shanghai Henlius Biotech. Earlier in October, Teva announced that the FDA and EMA accepted applications for its proposed Prolia® biosimilar TVB-009P.
Organon and Teva's applications join Celltrion, Fresenius Kabi, and Samsung Bioepis's applications for denosumab biosimilars CT-P41, FKS518, and SB16, respectively, which are awaiting FDA approval. In March 2024, Sandoz's Jubbonti® / Wyost® (denosumab-bddz) was FDA-approved as interchangeable with Prolia® / Xgeva®.
Litigations are ongoing between Amgen and Celltrion (Case No. 1:24-cv-06497 (D.N.J.)), Samsung Bioepis (Case No. 1:24-cv-08417 (D.N.J.)), and Fresenius Kabi (Case No. 1:24-cv-0955 (N.D. Ill.)) (previously reported Amgen Files BPCIA Lawsuit Against Celltrion's Proposed Prolia® / Xgeva® (Denosumab) Biosimilar CT-P41; Amgen Files BPCIA Lawsuit Against Samsung Bioepis Prolia® / Xgeva® Proposed Biosimilar SB16; Amgen Files Fourth BPCIA Lawsuit Against Proposed Prolia® / Xgeva® Biosimilar – Fresenius Kabi's FKS518). Amgen and Sandoz settled their lawsuit (Case No. 1:23-cv-02406) in April 2024, with a U.S. market entry date for Jubbonti® / Wyost® by May 31, 2025, or earlier under certain undisclosed circumstances (previously reported Amgen and Sandoz Settle Prolia® / Xgeva® Biosimilar Litigation).
The author would like to thank April Breyer Menon for her contributions to this article.
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