Amgen Sues Fresenius to Block Biosimilars of Prolia, Xgeva Drugs

Fresenius SE & Co.‘s proposed biosimilar versions of Amgen Inc.'s Prolia and Xgeva infringe 33 patents for the blockbuster bone-strengthening drugs, a federal lawsuit says.

Amgen’s patents cover denosumab—the active ingredient in both biologics—along with methods of manufacturing and using it, and products containing it, according to a complaint filed Oct. 4 in the US District Court for the Northern District of Illinois. Prolia and Xgeva’s combined domestic sales acounted for more than 15% of Amgen’s 2023 revenue, according to data compiled by Bloomberg.

• Fresenius, which Amgen said refused to provide “information describing the location of and processes used ...