Momenta and Mylan initiate Phase I clinical trial for Orencia (abatacept) biosimilar

November 3, 2016 6:47 AM


Momenta Pharmaceuticals, Inc. and Mylan N.V., 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.

“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,” said Craig Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “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.”

Mylan President Rajiv Malik commented, “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. 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. To date, Mylan has invested more than $1 billion in our biologics and insulin analog programs.”

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.

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