Biologics and Biosimilars: Pharmacology, Regulatory Science, and Clinical Implications

An in-depth review of the pharmacological principles governing biologics, including monoclonal antibodies, fusion proteins, cytokines, and therapeutic enzymes, is presented in this chapter. It further examines the regulatory frameworks for biosimilar approval, the scientific basis of interchangeability, and the pharmacovigilance challenges unique to large-molecule therapeutics.