Momenta Pharma completes confirmatory Phase III trial for M 923 (adalimumab biosimilar) for plaque psoriasis.

Momenta Pharmaceuticals, Inc. has announced that the confirmatory Phase III clinical study of M 923, a biosimilar Humira (adalimumab) candidate developed in collaboration with Baxalta, now part of Shire plc, in patients with moderate-to-severe chronic plaque psoriasis, met its primary endpoint.The proportion of subjects in the study who achieved the primary endpoint, at least 75% reduction in the Psoriasis Area and Severity Index (PASI-75) following 16 weeks of treatment, was equivalent between M 923 and Humira. The estimated difference in responders was well within the pre-specified confidence interval, confirming equivalence. Equivalence was also achieved in all secondary efficacy endpoints, including the achievement of PASI-50, PASI-90, proportion achieving clear or near-clear skin, and change from baseline in absolute PASI score. Adverse events were comparable in terms of type, frequency, and severity, and were consistent with the published safety data for Humira. This was a confirmatory, randomized, double-blind, multicenter study evaluating the efficacy, safety and immunogenicity of M 923 in adult patients with moderate-to-severe chronic plaque psoriasis. Patients received up to 48 weeks of treatment with M 923, Humira, or Humira alternating with M 923. The full dataset from this study will be presented at future conferences and in future publications.

In 2011, Momenta Pharmaceuticals and Baxter Bioscience (subsequently Baxalta), now part of Shire, entered into the collaboration to develop and commercialize M 923. Earlier this year, Shire announced it had made a strategic decision to end its biosimilars program and is now in the process of transitioning M 923 to Momenta Pharmaceuticals, enabling Shire to further pursue its focus on serving people with rare diseases and other highly specialized conditions.

Comment: Note that AbbVie claims that its patents extend to 2022.