Baxalta and Momenta announce initiation of pivotal clinical trial for M923, a biosimilar version of HUMIRA

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.

"We are committed to expanding treatment access and providing additional options for patients who suffer from chronic plaque psoriasis," said Dagmar Rosa-Bjorkeson, executive vice president and president, Biosimilars, Baxalta. "Chronic plaque psoriasis is a debilitating disease that can have a significant impact on a patient’s quality of life and physical wellbeing. We look forward to bringing a high-quality and cost-effective biosimilar version of adalimumab to patients around the world."

Chronic plaque psoriasis is the most common form of psoriasis that affects one to three percent of the general population1. It is characterized by scaly plaques or lesions on the body and the scalp, which may itch or sting, and can bleed when injured. Though there are treatments available, there is no cure for psoriasis.

"We believe that our extensive analytical and biocharacterization work has allowed us to create a high-quality biosimilar candidate of HUMIRA," said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals.
"We look forward to progressing M923 toward regulatory approval and commercialization with our collaborative partner Baxalta and to the potential of providing a more affordable biosimilar option for the many patients suffering from chronic autoimmune and inflammatory diseases."

This milestone is part of a global collaboration between Baxalta and Momenta to develop and commercialize M923. With this collaboration, Baxalta leverages its leading clinical development, biologic manufacturing expertise, and global commercial capabilities, while Momenta provides its expertise in high-resolution analytics, characterization, clinical and regulatory strategy for complex products, and product and process development.

M923 is developed in collaboration by Momenta and Baxalta Incorporated. HUMIRA, the largest selling therapeutic on the market today, is a significant intervention for patients with autoimmune/inflammatory diseases.

Adalimumab is used to treat many such conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.