EDRA 532 - Regulation of Biologics and Biosimilars

This course covers major steps concerning the manufacturing process of biologics and biosimilars. Moreover, the course focuses on the quality aspects relating to biologics and biosimilars and the comparability exercises mandated by rigorous regulatory bodies to demonstrate biosimilarity between the reference product and its biosimilar. Topics relating to physicochemical analysis, high-order structure determination, and purity demonstration will be covered. Preclinical and clinical studies needed to demonstrate the safety and efficacy of biologics will be discussed. Consideration is also given to their regulatory and control aspects including the existing regulatory guidelines of the US-FDA, EMA, WHO, and compare them to the SFDA guidance.