Amgen Says Dr. Reddy’s, Amneal Biosimilars Infringe Patents

Amgen Inc. filed patent infringement lawsuits against competitors Dr Reddy’s Laboratories Ltd and Amneal Pharmaceuticals Inc. over proposed biosimilar versions of its drugs preventing bone fractures in osteoporosis and cancer patients.

The proposed biosimilars infringe 31 patents protecting denosumab, the active ingredient in Prolia and Xgeva, according to the separate complaints Amgen filed Thursday in the US District Court for the District of New Jersey.

Amgen said Dr. Reddy’s and Amneal didn’t disclose information describing the process used to manufacture their biosimilar products, putting them out of compliance with the Biologics Price Competition and Innovation Act. That’s prevented Amgen from ...