Baxalta and Momenta report positive trial data for Humira biosimilar

Baxalta and Momenta Pharmaceuticals have reported positive data showing the promise offered by their new biosimilar version of the anti-inflammatory therapy Humira.

The new product, M923, met its primary endpoint in a randomised three-arm single-dose study, which aimed to evaluate the pharmacokinetics of M923 compared to both US and EU-sourced Humira reference products.

In addition to showing bioequivalence in pharmacokinetics, this study also demonstrated the new biosimilar offered comparable safety, tolerability and immunogenicity performance compared to the original drug.

Humira, also known as adalimumab, is used in the treatment of chronic inflammatory diseases, including chronic plaque psoriasis. A separate study assessing the effectiveness of M923 in the treatment of this condition commenced in October.

Dr John Orloff, head of research and development and chief scientific officer at Baxalta, said: "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."

A first regulatory submission for M923 is anticipated in 2017, with a first commercial launch potentially following as early as 2018.