Baxalta and Momenta announce M923 (Humira biosimilar) met primary endpoint in PK study

December 23, 2015 7:41 AM

Baxalta Incorporated and Momenta Pharmaceuticals, Inc., 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.

“We are encouraged by the results of this study,” said John Orloff, M.D., head of Research & Development and chief scientific officer, Baxalta. “We are committed to expanding treatment access and providing additional options for patients who suffer from chronic inflammatory diseases. We look forward to bringing a biosimilar version of adalimumab to patients around the world.”

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.

“The results of this PK study further validate our ability to develop high-quality biosimilar candidates using our complex systems analysis platform,” said Jim Roach, M.D., Senior Vice President of Development and Chief Medical Officer of Momenta Pharmaceuticals. “We are pleased with the results seen to date and expect that the data we generate from our ongoing pivotal trial in patients with chronic plaque psoriasis will continue to support the demonstration of biosimilarity of M923 to branded Humira.”

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 and 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.

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.


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