Baxalta, Momenta biosimilar Humira meets endpoints

Baxalta Inc. (NYSE:BXLT) and Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) said M923, their proposed biosimilar of Humira adalimumab, met the primary endpoint in a head-to-head pharmacokinetic study. The partners said they expect to begin regulatory submissions of M923 in 2017.

The partners said M923 showed bioequivalence to Humira in the 324-patient PK study. Safety and immunogenicity also were comparable. ...