Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Glivec, and do not need to be repeated for Imatinib Accord.

As for every medicine, the company provided studies on the quality of Imatinib Accord. The company also carried out studies that showed that it is ‘bioequivalent’ to the reference medicine, Glivec. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.