Momenta Pharmaceuticals, Inc. and Mylan NV, announced that dosing has begun in a phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834, a proposed biosimilar of Orencia (abatacept), to US- and EU-sourced Orencia in normal healthy volunteers. Under the Momenta-Mylan collaboration agreement,
Momenta has achieved the milestone necessary to earn a $25 million payment from Mylan.
The phase 1 study is a randomized, double-blind, three-arm, parallel group, single-dose study that is expected to enroll approximately 300 healthy volunteers. The companies plan to report top-line data from this study by the end of 2017.
M834 is developed in collaboration by Mylan NV and Momenta Pharmaceuticals. Orencia is a fusion protein and the only CTLA-4Ig approved in the US, EU and Japan for the treatment of rheumatoid arthritis and the US and EU for the treatment of juvenile idiopathic arthritis. In 2015, worldwide sales of Orencia totaled $1.9 billion.