Quality similarity-driven development of biosimilar monoclonal antibodies

Abstract

The number of approved and marketed biosimilar monoclonal antibodies has been increasing steeply in recent years in regulated markets. In contrast to small molecular generic drugs, structure and variant profile of biosimilar mAbs are not identical with those of the reference medicinal product. Biosimilarity is proven by using the “totality of evidence” approach, and it forms the basis of the approval process of biosimilars in regulated markets. This process includes a comprehensive quality similarity exercise. This step involves the evaluation of all physico-chemical and biological-functional characteristics. The present paper evaluates the analytical similarity approaches taken through the evaluation of quality attributes of recently approved biosimilar mAbs.