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.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Robert S. Schwartz, Ph.D.
Venable LLP
Rockefeller Center, 1270 6th Ave
New York
NY 10020
UNITED STATES
URL: www.Venable.com

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