Fresenius Kabi has signed a worldwide settlement and license agreement with AbbVie, settling all pending patent litigations between the two companies. Under the terms of the agreement and subject to marketing authorization by the health authorities, Fresenius Kabi’s biosimilar candidate of Humira®* (adalimumab), MSB11022**, could be commercialized in the United States from September 30, 2023.
On October 17, 2018 licenses under the agreement came into effect in certain countries in Europe in which AbbVie owns intellectual property. The application for marketing authorization for MSB11022 was submitted by Fresenius Kabi to the European Medicines Agency (EMA) at the end of last year. The dossier is currently under review. A first launch in Europe is expected in the first half of 2019.
“This agreement is a major step on our way to successfully developing and commercializing our biosimilar portfolio," said Dr. Michael Schönhofen, Member of the Fresenius Kabi Management Board and President of the Pharmaceuticals Division. “In line with our caring for life philosophy, our aim is to contribute to broader access to affordable therapies for chronic and acute diseases. Biosimilar drugs are an increasingly important component in reaching this aim – to the benefit of patients and healthcare systems. The agreement with AbbVie provides further clarity regarding when we will be able to commercialize our biosimilar candidate of Humira®.”
*Humira® (adalimumab) is a registered trademark of AbbVie Biotechnology Ltd.
**MSB11022 is being developed as a biosimilar candidate of Humira® and is not yet approved by health authorities.