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Fresenius Kabi Announces FDA Acceptance of aBLA for Prolia® / Xgeva® (denosumab) Biosimilar Candidate FKS518

by Robert S. Schwartz, Ph.D.
May 28, 2024

On May 27, 2024, Fresenius Kabi announced the FDA acceptance of its aBLA for FKS518 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab).  This is the third publicly announced aBLA for a Prolia® / Xgeva® biosimilar; Sandoz’s Jubbonti® / Wyost® (denosumab-bddz) was approved as interchangeable on March 5, 2024, and Celltrion’s CT-P41 (denosumab) aBLA is pending (submitted to the FDA in November 2023).

At the end of April 2024, Amgen and Sandoz settled a BPCIA litigation related to a denosumab biosimilar (Case No. 1:23-cv-02406 (D.N.J.)), agreeing to an injunction until February 19, 2025, with a 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).

According to Bloomberg, combined U.S. sales for Prolia® ($2.7 B) and Xgeva® ($1.5B) accounted for more than 15% of Amgen’s 2023 total revenue.

For more information about these and other biosimilar aBLAs and 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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