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®1 (adalimumab), MSB110222, 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.
1 Humira® (adalimumab) is a registered trademark of AbbVie Biotechnology Ltd.
2 MSB11022 is being developed as a biosimilar candidate of Humira® and is not yet approved by health authorities.