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Prolia® / Xgeva® Biosimilar Updates: Alvotech / Dr. Reddy’s AVT03 aBLA Acceptance, Fresenius Kabi’s Conexxence™ / Bomyntra™ FDA-Approval

by Robert S. Schwartz, Ph.D.
March 31, 2025

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®.

For more information about these and other biosimilars and biosimilar patent disputes related to Prolia® / Xgeva®, 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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