Type of information: Licensing agreement
Compound: MSB11022 - biosimilar version of Humira® (adalimumab)
Company: Abbvie (USA - IL) Fresenius Kabi (Germany)
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases - Dermatological diseases
Type agreement: licensing
- monoclonal antibody/biosimilar product/TNF alpha inhibitor. MSB11022 is a biosimilar version of the monoclonal antibody adalimumab (Humira®). Adalimumab specifically binds to tumor necrosis factor (TNF)-alpha. Samsung Bioepis has initiated a phase 3 study in psoriasis in 2015.
- • On October 18, 2018, Fresenius Kabi announced that they have reached a global agreement with AbbVie regarding Fresenius Kabi’s adalimumab, MSB11022, a biosimilar candidate of AbbVie’s Humira®. 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.