Biography
Biography: Andras Guttman
Abstract
Recent expiration of a number of protein therapeutics opened up the door for biosimilar development. Biosimilars are biologic medical products, which are similar but not identical copies of already authorized protein therapeutics. Critical Quality Attributes (CQA) such as post translational modifications of recombinant biotherapeutics, are important for clinical efficacy and safety of both the innovative biologics and their biosimilar counterparts. The first part of this presentation summarizes biosimilarity CQAs, considering the regulatory guidelines and the statistical aspects (e.g., biosimilarity index). The second part discusses glycosylation as one of the important attributes of biosimilarity in detail. Finally, the term of glycosimilarity index is introduced, based on the averaged biosimilarity criterion.