The First Prolia® / Xgeva® Biosimilar Approvals in the U.S. | Venable LLP
On March 5, 2024, the FDA approved Sandoz’s Jubbonti® and Wyost® (denosumab-bddz) as the first biosimilars of Amgen’s Prolia® and Xgeva® (denosumab). The launch date for these biosimilars has not been announced as Amgen and Sandoz continue their BPCIA litigation in the district of New Jersey.
Amgen filed its BPCIA Complaint (1:23-cv-02406 (D.N.J.)) on May 01, 2023, asserting that Sandoz’s aBLA for Jubbonti® / Wyost® infringed twenty-one of Amgen’s patents covering the reference products. Among these patents, two include formulation claims, three include composition of matter claims, and 20 include manufacturing claims.
On September 8, 2023, Amgen brought a motion for preliminary injunction and hearings were held in October through December 2023. A decision on the preliminary injunction is pending. Sandoz was instructed to provide the Court with 30-days notice in advance of launching its biosimilar products, and to provide an update on the proposed target launch date by March 1, 2024. Sandoz’s communication with the Court regarding launch remains under seal. We continue to monitor this docket and will provide any updates once available.
As we have previously reported (see Celltrion Completes Application for FDA Approval of CT-P41, Biosimilar of Prolia® / Xgeva®), Celltrion also filed an aBLA for its denosumab biosimilar, CT-P41, that is currently pending.
Amgen reported 2023 U.S. sales of $2.7 billion for Prolia® and $1.5 billion for Xgeva®.
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The author would like to thank April Breyer Menon for her contributions to this article.
