Date: 2016-06-08
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the European League Against Rheumatism Annual Congress (EULAR) 2016 Annual Meeting in London
Company: Momenta Pharmaceuticals (USA - MA) Baxalta (USA - IL)
Product: M923, a biosimilar version of Humira® (adalimumab)
Action
mechanism: biosimilar/monoclonal antibody/TNF alpha inhibitor. M923 is a biosimilar version of Humira® (adalimumab) developed in collaboration with Baxter. The largest selling therapeutic on the market today, Humira is a transformative therapy for patients with autoimmune/inflammatory diseases. Humira is used to treat many conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and plaque psoriasis. M923 is developed in collaboration by Momenta and Baxalta.
Disease:
Therapeutic area: Autoimmune diseases – Inflammatory diseases
Country:
Trial details:
Latest
news: * On June 8, 2016, Momenta Pharmaceuticals announced that key data from a pharmacokinetic/safety study of M923, a biosimilar candidate developed in collaboration with Baxalta, now part of Shire, will be presented at the European League Against Rheumatism Annual Congress (EULAR) 2016 Annual Meeting in London. * On December 21, 2015, Baxalta and Momenta Pharmaceuticals announced that M923 met the primary endpoint in a randomized, double-blind, three-arm, parallel group, single-dose study. The primary objective of the study was to evaluate the pharmacokinetics of M923 compared to both U.S. and EU sourced Humira® reference products. In addition to showing bioequivalence in pharmacokinetics, this study also evaluated safety, tolerability and immunogenicity following single doses of M923 given by injection. The safety profile and immunogenicity were also found to be comparable. A total of 324 healthy volunteers were enrolled in the study. Baxalta and Momenta announced the initiation of a separate pivotal clinical trial of M923 in chronic plaque psoriasis in October 2015. The companies are targeting a first regulatory submission in 2017 and a first commercial launch as early as 2018.
The poste summarizes topline results for a randomized, double-blind, three-arm, parallel group, single-dose study that was designed jointly by Momenta, Baxalta, and Quintiles, met its primary endpoint late last year.
(Poster #FRI0182: A Single Dose Study Comparing Pharmacokinetics, Safety, and Immunogenicity of M923 (a Proposed Biosimilar to Adalimumab), US-Sourced Adalimumab, and EU-Sourced Adalimumab in Healthy Subjects)
