Momenta and Mylan reported unexpected results for proposed Orencia biosimilar

November 10, 2017 6:14 AM


Momenta Pharmaceuticals, Inc. and Mylan N.V. have last week announced that M834, a proposed biosimilar of Orencia (abatacept), did not meet its primary pharmacokinetic (PK) endpoints in the Phase I study.

The study was conducted to compare the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced Orencia in normal healthy volunteers. Momenta and Mylan continue to gather and analyze these data to inform next steps for the program.

“This was an unexpected result and we are disappointed with the outcome of this PK study,” said Craig Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “We are in the process of gathering the full data set and will work with Mylan to fully analyze these data to better understand the study results and evaluate next steps for this program. We remain committed to executing on our biosimilar portfolio.”

The Phase I study was a randomized, double-blind, three-arm, parallel group, single-dose subcutaneous administration clinical study to compare the pharmacokinetics, safety, and immunogenicity of M834, US-sourced Orencia, and EU-sourced Orencia in 243 normal healthy volunteers.

Orencia is a fusion protein and the only CTLA-4Ig approved in the US, EU, and Japan for the treatment of Rheumatoid Arthritis and in the US and EU for the treatment of Psoriatic Arthritis and Juvenile Idiopathic Arthritis. In 2016, worldwide sales of Orencia totaled $2.4 billion.


Source: Momenta Pharmaceuticals

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