Phase III trial success for M 923 (adalimumab biosimilar)-Baxalta + Momenta Pharma

Baxalta Incorporated and Momenta Pharmaceuticals, Inc. announced that M 923 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 (adalimumab) reference products. In addition to showing bioequivalence in pharmacokinetics, this study also evaluated safety, tolerability and immunogenicity following single doses of M 923 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.

Comment: Baxalta and Momenta announced the initiation of a separate pivotal clinical trial of M 923 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.

Comment: The patents protecting Humira from biosimilar competition are set to expire at the end of 2016,( though AbbVie claims patents extend to 2022 and beyond) and a growing number of competitors are advancing to the market. Amgen has submitted its biosimilar candidate for FDA approval, and following is a group that includes Novartis/Sandoz and Merck which is working with Samsung Bioepis.