Amgen sues Samsung biologics unit over biosimilar for bone disease

Samsung Bioepis, the biologics unit of Samsung, has been issued a lawsuit brought forth by Amgen over proposed biosimilars of Amgen’s bone drugs Prolia and Xgeva. 

The lawsuit claims that Samsung Bioepis’ biosimilar products infringe up to 34 patents covering Amgen’s blockbuster drugs. The claim also includes a request to block Samsung Bioepis from continuing to make and sell their drug products, with an unspecified amount of monetary damage. Amgen claims that Samsung Bioepis’ biosimilars infringe patents covering the API denosumab found in Prolia and Xgeva, as well as technology related to the drugs. 

Biosimilars are biologic drug products akin to generics for traditional pharmaceuticals. They are complex products made from living cells or tissues, and cannot be copied exactly. In a statement to the court, Amgen stated that Samsung had applied for US FDA permission to market biosimilars of Prolia and Xgeva. Prolia is used in patients with osteoporosis and those at high risk for broken bones, while Xgeva aids in preventing fractures in patients with bone cancer. Over US$2.7 billion worth of Prolia was sold in the US last year, while Xgeva saw sales of up to US$1.5 billion. A similar dispute was brought forth between Amgen and Sandoz after the FDA granted approval to biosimilars developed and marketed by Sandoz. 

Both Amgen and Samsung declined to comment on the lawsuit. 

Source: 

Amgen sues Samsung biotech unit over bone drug copies [Accessed August 14, 2024] https://www.reuters.com/legal/litigation/amgen-sues-samsung-biotech-unit-over-bone-drug-copies-2024-08-13/