Amgen sues Novartis' Sandoz for alleged infringement on bone drugs Xgeva, Prolia

Amgen is taking Novartis’ Sandoz to court over the latter company's proposed biosimilar candidate to its aging bone meds Prolia and Xgeva.

The California-based biotechnology giant filed the complaint in a New Jersey federal court in response to Sandoz’s FDA application for the biosimilar, which the FDA accepted in February.  

Back in December, Sandoz notified Amgen of its FDA submission and provided a copy of its biologic license application, Amgen said in the suit. 

But Amgen argues Sandoz failed to turn over details about the biosimilar's manufacturing process as required by the Biologics Price Competition and Innovation Act. Amgen also claims that an FDA approval decision on the biosimilar candidate could come before its relevant patents expire.

The company scored patents on Prolia and Xgeva between 2008 through 2022. The last one expires in July 2037, according to the lawsuit.

Prolia was the first biologic approved to treat osteoporosis while Xgeva targets bone cancer. Both drugs contain denosumab as their active ingredient and won their original FDA approvals in 2010. The meds have racked up multiple other bone-related indications since their original nods.

Amgen is seeking a judgment of infringement and an injunction prohibiting the production and sale of the proposed biosimilar prior to the patent expiration dates, a spokesperson said over email.

Novartis’ Sandoz did not immediately respond to a request for comment.

This isn’t the first time Amgen and Sandoz have battled in court. Just last month, Amgen won an appeal against Sandoz and Zydus, blocking the partners from launching their proposed Otezla generic until February 2028. Amgen inherited that suit from Otezla’s original maker, Celgene.

As for Sandoz, the Novartis unit is preparing to fly the nest and spin off into the world’s largest generics company in the second half of this year. This week, the company snapped up six small-molecule generic candidates from Malta-based pharma company Adalvo.

Prolia generated sales of $3.6 billion last year, good for 12% growth from 2021. Xgeva brought in flat sales of $2 billion.