Amgen sues Samsung biotech unit over bone drug copies

Aug 13 (Reuters) - Amgen (AMGN.O) has sued Samsung's biologics unit (207940.KS) in New Jersey federal court over its proposed biosimilar versions of Amgen's blockbuster bone drugs Prolia and Xgeva.

Amgen's lawsuit against Samsung Bioepis, filed on Monday, said the biosimilars would infringe 34 patents covering Amgen drugs. It requested an order blocking Samsung from making and selling the drugs and an unspecified amount of monetary damages.

Spokespeople for Amgen and Samsung Bioepis did not immediately respond to requests for comment on the complaint on Tuesday.

Biosimilars are versions of biologic drugs that are comparable to generics of traditional pharmaceuticals. Unlike traditional drugs, complex biologic drugs are made from living cells and cannot be copied exactly.

Thousand Oaks, California-based Amgen told the court on Monday that Samsung had applied for permission from the U.S. Food and Drug Administration to market biosimilars of Prolia, which treats patients suffering from osteoporosis and others at high risk for bone breaks, and Xgeva, which prevents fractures in bone-cancer patients.

Amgen sold more than $2.7 billion worth of Prolia and $1.5 billion of Xgeva in the United States last year, according to a company report. The FDA granted approval in March for Sandoz to market the first biosimilars of the drugs, which will be available in the U.S. by May 2025 following the settlement of a separate patent dispute between Sandoz and Amgen.

Amgen told the court that Samsung's biosimilars would infringe patents covering Prolia and Xgeva's active ingredient denosumab and other technology related to the drugs.

The case is Amgen Inc v. Samsung Bioepis Co, U.S. District Court for the District of New Jersey, No. 1:24-cv-08417.