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Drug Regulators, EMEA, Publish Concept Paper on the Development of a Guidance on Similar Biological Medicinal Products Containing Monoclonal Antibodies

Filed in manufacturing,regulatory, December 27, 2009, 8:34 am , , , , , ,

Monoclonal Antibodies (mAbs) comprise a large important class of therapeutic biologicals. Different mAb products share some properties, e.g. on a functional level, but differ in aspects like the mechanism of action. The complexity of mAbs is a challenge for the development of new mAb products that are claimed to be similar to marketed mAbs. Nevertheless, such mAbs are being developed, and CHMP has given scientific advice for the development of some individual products.