Fresenius SE & Co. KGaA (FRE.XE) said Monday that it has submitted a biosimilar marketing authorization application to the European Medicines Agency for adalimumab.
This is the first biosimilar regulatory filing for Fresenius Kabi, the generic drugs unit, the company said. Fresenius acquired its adalimumab biosimilar this year when it bought Merck KGaA’s (MRK.XE) biosimilars business.
Fresenius’s drug is a biosimilar candidate of AbbVie Inc.’s (ABBV) Humira, which is used to treat chronic inflammatory autoimmune conditions such as arthritis and Crohn’s disease.
Write to Sonia Amaral Rohter at [email protected]
(END) Dow Jones Newswires