On March 18, 2025, Alvotech and Dr. Reddy’s announced the FDA acceptance of an aBLA for AVT03 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab). Under their agreement, Alvotech is responsible for the development and manufacture of AVT03, and Dr. Reddy’s is responsible for its registration and commercialization.
On March 25, 2025, the FDA approved Fresenius Kabi’s Conexxence™ / Bomyntra™ (denosumab-bnht) as the fourth biosimilars of Prolia® / Xgeva®. Earlier in March, Fresenius Kabi settled its BPCIA litigation with Amgen, Case No. 1:25-cv-01080 (D.N.J.) / MDL 1:25-md-03138 (D.N.J.), allowing a launch in June 2025 (previously reported Prolia® / Xgeva® (denosumab) Biosimilar Updates: Celltrion Biosimilar Approval, Amneal aBLA Filing, and Fresenius Kabi Litigation Settlement).
Numerous aBLAs are pending at the FDA for Prolia® / Xgeva® biosimilars, including Teva’s TVB-009P, Organon / Shanghai Henlius Biotech’s HLX14, Accord / Intas’s INTP23, Gedeon Richter / Hikma’s RGB-14, and Amneal / mAbxience’s denosumab.
Amgen reported FY24 U.S. sales for Prolia® of $2.885 billion, and $1.507 billion for Xgeva®.
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The author would like to thank April Breyer Menon for her contributions to this article.
