First patient in Momenta, Mylan M834 trial is dosed

Momenta Pharmaceuticals and Mylan N.V.'s first patient in its Phase 1 study of M834 has been dosed. The trial will evaluate M834's pharmacokinetics, safety and immunogenicity.
"We are deeply committed to expanding treatment access and providing high-quality and affordable biosimilar options for patients who suffer from autoimmune and inflammatory diseases," Momenta President and CEO Craig Wheeler said. "Our collaboration with Mylan, one of the largest generics and specialty pharmaceutical companies in the world, positions us to advance this important biosimilar candidate through the clinic. We believe we have the opportunity to be the leader in offering patients a biosimilar version of ORENCIA."
According to the agreement, Momenta has surpassed the milestone that has warranted a $25 million payment from Mylan.
"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," Rajiv Malik, president of Mylan, said. "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.