Phase 1 Clinical Trial Launched for Orencia Biosimilar

Momenta and Mylan have announced that dosing has begun in a phase 1 study for M834, the proposed biosimilar of Orencia (abatacept).

The objective of the trial is to gauge the pharmacokinetics, safety, and immunogenicity of M834 in healthy volunteers. Orencia is a fusion protein and the only CTLA-4lg approved in the United States, European Union, and Japan for the treatment of rheumatoid arthritis.

The phase 1 study for M834 is a randomized, double-blind, 3-arm, parallel group, single-dose study that will involve approximately 300 participants.

“Our pipeline of biosimilar products, which is one of the largest in development in the industry, continues to make exciting advancements, and today's milestone for M834 is yet another example of this progress,” said Mylan president Rajiv Malik in a press release. “Our partnership with Momenta is based not only on a shared commitment to bringing more affordable versions of critical biologic products to patients around the world, but also on our mutual passion for science and R&D, and our willingness to invest in it.”

The most common adverse effects associated with Orencia are headache, upper respiratory tract infection, sore throat, and nausea. In children, adverse effects including diarrhea, cough, fever, and abdominal pain have been reported. Top-line data from the study are expected to be reported by the end of next year.