Amid patent fight, Sandoz biosimilars to Amgen bone blockbusters gain FDA nods

Two biosimilars to Amgen’s lucrative bone drugs Prolia and Xgeva have clinched approvals at the FDA, though ongoing patent litigation makes launch timing uncertain.

Copycat drugs giant Sandoz—which spun off from Novartis last fall—has clinched U.S. approvals for biosimilars to Amgen’s denosumab, Jubbonti and Wyost, which reference their respective brand-name counterparts Prolia and Xgeva.

Sandoz’s drugs mark the first approved denosumab biosimilars and treat all indications of the reference products, the company said in a press release.

Prolia and Xgeva are discrete brand names for the same Amgen antibody, denosumab. Prolia bears the distinction of being the first biologic approved to treat osteoporosis, while Xgeva targets bone cancer.

Both drugs won their initial approvals in 2010 and have racked up multiple other bone-related indications since their original nods.

Last year, Prolia sales increased 12% to more than $4 billion, while Xgeva revenues climbed 5% to $2.1 billion, Amgen noted in its latest earnings report.

Aside from being the first-approved biosimilars to Prolia and Xgeva, Sandoz’s Jubbonti and Wyost are interchangeable, too, which means they can be subbed in for their reference products without approval from the prescriber, similar to the process for dispensing small molecule generics.

Still, given legal skirmishing over Amgen-owned patents, Sandoz declined to comment on anticipated launch timing or launch plans.

Last year, Amgen filed a complaint against Sandoz in a New Jersey federal court, claiming infringement of more than 20 Prolia and Xgeva patents, the company explained in a recent securities filing.

Amgen further claimed Sandoz failed to turn over details about its biosim manufacturing process as required by law. Amgen also argued that an FDA approval decision on the biosimilars would come before its relevant patents expire.

Amgen’s last denosumab patent is set to run out in July 2037, according to the company’s lawsuit.