Abstract

Biologics, including biosimilars and their reference products, are complex compounds created in living systems by biotechnology. Multiple tiers of sophisticated, highly regulated manufacturing processes are combined with preclinical structural, functional, and biological assessments, as well as clinical efficacy and safety, including immunogenicity, investigations in the creation of biologics. Additionally, to ensure a high degree of similarity, a biosimilar must go through a comparability exercise at every stage of development, as outlined by regulatory agencies, to show that potential differences from the reference product are not clinically meaningful in terms of quality, safety, and efficacy (European Medicines Agency [EMA]) or safety, purity, and potency (US Food and Drug Administration [FDA]). The formation of a high degree of structural similarity with its reference product is at the heart of the biosimilar development process. To establish a high level of structural and functional resemblance, cutting-edge technology must be used.