Big Molecule Watch
November 29, 2016

Momenta Announces Positive Phase III Results For Its Humira biosimilar

Today Momenta Pharmaceuticals announced that M923, a biosimilar candidate of AbbVie’s Humira (adalimumab), met the primary endpoint in a Phase III trial of M923 for treatment of patients with moderate-to-severe chronic plaque psoriasis.  According to Momenta, M923 also achieved all secondary endpoints and adverse events were comparable to Humira.

As we reported previously, Momenta developed M923 in collaboration with Baxalta, but the collaboration was terminated in September after Shire acquired Baxalta.  Momenta previously indicated and recently reiterated a target date for regulatory submission in mid-2017 and a target launch date as early as 2018, depending on the timelines for approval and anticipated patent litigation against Amgen.

Stay tuned to Big Molecule Watch for further developments.