BioCentury
ARTICLE | Politics & Policy

EMA releases updated guidelines for biosimilar insulin products

December 20, 2012 1:32 AM UTC

EMA's CHMP released draft guidelines that update 2006 guidelines on the non-clinical and clinical requirements for biosimilar insulin products. The updated guidelines state that clinical studies should be double-blinded insulin "clamp" studies in which a subject's plasma insulin concentration is raised while the glucose-infusion rate (GIR) is "clamped" at a certain level through the infusion of glucose. EMA now recommends both area under the curve (AUC) and maximum plasma concentration (Cmax) as primary pharmacokinetic endpoints for biosimilar insulin products, and GIR AUC and GIRmax as primary pharmacodynamics endpoints. Additionally, the guidelines state the clinical studies can include normal-weight healthy volunteers or Type I diabetics; EMA previously recommended that clinical studies be performed only in diabetics. ...