Defendant
1 case as defendant.
mAbxience S.A.U. is a global biotechnology company specializing in the development, manufacture, and commercialization of biologics and biosimilars. Headquartered in Madrid, Spain, the company was founded in 2010 as the biotechnology arm of Insud Pharma. In August 2022, Fresenius Kabi, an operating company of Fresenius, acquired a majority 55% stake in mAbxience, making it a subsidiary while Insud Pharma retains partial ownership. mAbxience operates with a team of over 1,000 professionals and has estimated annual revenues ranging from $50 million to $250 million.
The company provides end-to-end Contract Development and Manufacturing Organization (CDMO) services for biopharmaceuticals, including cell line development, drug substance manufacturing, and regulatory services. mAbxience focuses on therapeutic areas such as oncology, immunology, neurology, and infectious diseases. It maintains state-of-the-art GMP multi-product manufacturing facilities in Spain and Argentina, with a combined bioreactor capacity of 50,000 liters. Its product portfolio includes commercialized biosimilar medicines for oncology, MB01 rituximab biosimilar and MB02 bevacizumab biosimilar, and it recently received European Commission approval for its denosumab biosimilars, Denbrayce® and Izamby®.
In terms of patent litigation, mAbxience S.A.U. appears to be an operating company that defends against infringement allegations. The company has been involved in one tracked case, solely as a defendant, indicating a defensive litigation posture rather than an assertive one.
The sole tracked case is Amgen Inc. v. Amneal LLC et al., filed in the District of New Jersey in November 2025. mAbxience S.A.U. is named as a defendant, along with Amneal LLC and other entities. The complaint alleges that mAbxience collaborated with Amneal and others to develop, manufacture, seek regulatory approval for, market, distribute, and sell proposed denosumab biosimilar products, which Amgen claims infringe its patents related to Prolia® and XGEVA®.
Amgen filed this BPCIA action asserting infringement of several patents, including US Patent 7364736, against Amneal LLC and mAbxience S.A.U. for their proposed denosumab biosimilar products.