United States: Celltrion Completes Application For FDA Approval Of CT-P41, Biosimilar Of Prolia® / Xgeva®

On November 30, 2023, Celltrion announced that it filed for an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P41 (denosumab), a proposed biosimilar of Amgen's Prolia^® / Xgeva^® (denosumab). There is currently another pending aBLA for a proposed biosimilar of Prolia^® / Xgeva^® from Sandoz for GP2411, which was accepted by the FDA in February 2023. A litigation involving GP2411 was filed in May 2023 and is currently pending. Amgen, Inc. et al v. Sandoz, Inc. et al, No. 1:23-cv-02406 (D.N.J.). No patent disputes related to Celltrion's CT-P41 have been filed yet.

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