5:32 PM
Dec 19, 2012
 |  BC Extra  |  Politics & Policy

EMA releases updated guidelines for biosimilar insulin products

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...

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