A Regulatory Perspective on Testing of Biological Activity of Complex Biologics

Antibody–drug conjugates (ADCs) and bispecific antibodies are becoming increasingly popular. However, their complex structures mandate stringent regulatory guidelines to ensure their safety and efficacy. We have briefly reviewed the existing regulatory guidelines and presented our perspectives on refining them to hasten the transition of these drugs from laboratories to market. Antibody–drug conjugates (ADCs) and bispecific antibodies are...