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.
The author would like to thank April Breyer Menon for her contributions to this article.
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