Date: 2015-10-05
Type of information: Initiation of the trial
phase: 3a
Announcement: initiation of the trial
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: chronic plaque psoriasis
Therapeutic area: Autoimmune diseases – Dermatological diseases
Country: Canada
Trial
details: The purpose of the study is to evaluate efficacy, safety, and immunogenicity of a proposed adalimumab biosimilar (M923) and Humira in participants with moderate to severe chronic plaque-type psoriasis. (NCT02581345)
Latest
news: * On October 5, 2015, Baxalta and Momenta Pharmaceuticals announced the initiation of a pivotal clinical trial in patients with chronic plaque psoriasis for M923, a biosimilar version of Humira® (adalimumab). The trial is a randomized, double blind, active control, multi-center, global study in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with Humira®. The companies are targeting first regulatory submission in 2017 and a first commercial launch in 2018. * On December 1, 2014, Momenta Pharmaceuticals announced the acceptance by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a Clinical Trial Application (CTA) to initiate a clinical trial for M923, a biosimilar version of Humira® (adalimumab), in its collaboration with Baxter International's biopharmaceutical business. Acceptance of the CTA triggers two milestones under the Baxter collaboration with an aggregate payment of $12 million. Momenta expects to receive the payment in December 2014 . Momenta Pharmaceuticals looks forward to the initiation of the clinical study in first quarter of 2015.
