Sandoz plans to introduce an upcoming biosimilar this year but will now contend with immediate market competition after Amgen and Celltrion established a new agreement. Celltrion received approval to launch its Prolia and Xgeva biosimilar versions following a settlement agreement with Amgen that concluded a period of patent litigation.
Under the settlement terms, Celltrion admitted that its challenged denosumab patents were both enforceable and affected its biosimilar offerings currently under development in the U.S. market.
The settlement stands as a duplicate of another agreement Amgen made with Sandoz earlier last spring. Sandoz obtained FDA approval to release Prolia and Xgeva biosimilars beginning May 31 this year while specific ‘limited conditions’ allowed for earlier access.
Sandoz gained FDA authorization for its Prolia and Xgeva biosimilars named Jubbonti and Wyost in March of last year. Both Sandoz’s Jubbonti and Wyost serve as the initial U.S.-approved biosimilars to Amgen’s denosumab franchise while offering the added benefit of interchangeability since healthcare professionals can automatically substitute them for reference drugs through the standard generic dispensing system.
Celltrion lacks FDA approval for Prolia/Xgeva copycats named Stoboclo and Osenvelt despite filing the regulatory application with the U.S. agency. According to Business Korea’s report in Nov. 2023, Celltrion announced the submission of its biosimilar application to the FDA.
The approved drug Stoboclo received clearance from both EU regulators and Korean authorities while Osenvelt gained regulatory approval within EU and Korean territory.
The therapeutic duo of Prolia and Xgeva obtained FDA authorization in 2010 to treat both osteoporosis patients and solid tumor metastases patients with skeletal weakness. Each treatment uses denosumab RANK ligand inhibitor yet they have different prescription applications combined with different dose strengths and timing.
Prolia earned $2.1 billion from the US market through the first nine months of 2024 while Xgeva produced sales reaching $1.1 billion in that period. Amgen’s latest annual report indicates that both drugs will lose U.S. patent protection in February.
Sandoz looks set to launch its biosimilars first yet Celltrion’s upcoming launch strategy remains in question because it lacks an official FDA stamp of approval.
The FDA currently holds applications for Prolia and Xgeva biosimilars from both Sandoz and Celltrion and additionally Organon and Teva, Fresenius Kabi, and Samsung Bioepis. Following their copycat injection patent filings during October Amgen brought lawsuits against Sandoz as well as Celltrion Samsung Bioepis and Fresenius Kabi according to various online sources.
