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.

We continue to monitor this aBLA and will provide updates once available.  For more information on pending aBLAs and patent disputes related to biosimilars, please visit BiologicsHQ.