BioCentury
ARTICLE | Clinical News

Biosimilar Orencia from Momenta and Mylan misses in PK trial

November 3, 2017 6:30 AM UTC

Momenta Pharmaceuticals Inc. (NASDAQ:MNTA) and Mylan N.V. (NASDAQ:MYL; Tel Aviv:MYL) said their proposed biosimilar of Orencia abatacept, M834, missed the primary pharmacokinetic endpoints compared to U.S.- and EU-sourced Orencia in a Phase I trial in 243 healthy volunteers. The double-blind, U.K. trial evaluated pharmacokinetics, immunogenicity and safety of single doses of subcutaneous M834. The partners said they plan to analyze the data to determine next steps for the program.

Mylan has exclusive, worldwide rights to co-develop and commercialize M834 from Momenta under a 2016 deal (see BioCentury, Jan. 18, 2016)...