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FDA Accepts aBLAs for Prolia® / Xgeva® Biosimilars from Organon and Teva

by Robert S. Schwartz, Ph.D.
November 4, 2024

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).

For more information on pending aBLAs and biosimilar-related patent disputes, 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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