Momenta Pharmaceuticals announces acceptance of a clinical trial application in Europe for M923

December 2, 2014 7:12 AM

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today announced the acceptance by the UK MHRA of a Clinical Trial Application to initiate a clinical trial for M923, a biosimilar version of Humira® (adalimumab), in its collaboration with Baxter International’s biopharmaceutical business.

Acceptance of the Clinical Trial Application (CTA) triggers two milestones under the Baxter collaboration with an aggregate payment of $12 million. Momenta expects to receive the payment in December 2014.

“The European CTA acceptance for M923, our biosimilar version of Humira, represents a significant achievement by Momenta and Baxter in using the biosimilar regulatory pathway in an effort to expand patient choice,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “We look forward to the initiation of the clinical study in first quarter of 2015.”

Momenta is using its innovative technology to create a strong pipeline of biosimilars and potentially interchangeable biologics – a completely new segment of the biologics market. Momenta and Baxter have an ongoing collaboration for the worldwide development and commercialization of several biosimilar candidates at various stages of development, including M923 and M834.

About M923, a biosimilar version of Humira
M923 is a biosimilar version of Humira developed in collaboration with Baxter. The largest selling therapeutic on the market today, Humira is a transformative therapy for patients with autoimmune/inflammatory diseases. Humira is used to treat many conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.

About Momenta’s biosimilars program
Momenta is applying its complex systems analysis platform to obtain thorough analysis of its biosimilars in relation to the branded biologic. Current biosimilars are being developed and commercialized with an understanding that some aspects of the drug may be different from that of its brand name counterpart. These differences may lead to uncertainty as to how well the biosimilar can replicate the therapeutic effects of its branded counterpart and provide the same safety profile. Momenta is striving to remove that uncertainty and any qualitative product differences by creating thoroughly characterized products that are indistinguishable from the brand name drug.


Source: Momenta press release

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