title: Similar biotherapeutic products: overview and reflections.
abstract: Biotherapeutic products (BPs) have revolutionized medicine, changing the way we treat several pathologies such as autoimmune diseases and cancer, among others. Herein, we present an overview of similar BPs (SBPs), also called biosimilars, including the manufacturing process and regulatory aspects involved. The objective of developing an SBP is to manufacture a molecule that is highly similar to a reference BP by conducting a comparability exercise (CE) that can demonstrate similar safety and efficacy. This CE consists of quality, as well as nonclinical and clinical evaluation. A case-by-case analysis approach guided by scientific and objective standards must be the foundation for the SBP approval process. The establishment of a balance between a comprehensive CE for SBPs and their reference BPs, and the design of costeffective strategies to provide better access to BPs, should be the key goal for national regulatory authorities.
authors.affiliation: Center for Autoimmune Diseases Research (CREA), School of Medicine & Health Sciences, Universidad del Rosario, Carrera 24 # 63-C-69. Third Floor, Bogotá, Colombia.
authors.forename: Zayrho
authors.initials: Z
authors.lastname: Desanvicente-Celis
authors.forename: Arley
authors.initials: A
authors.lastname: Gomez-Lopez
authors.forename: Juan-Manuel
authors.initials: JM
authors.lastname: Anaya
mesh_terms: D000818:Animals; D001327:Autoimmune Diseases / Q000628:therapy*; D001691:Biological Therapy / Q000379:methods* / Q000639:trends; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D001709:Biotechnology; D017277:Drug Approval; D015195:Drug Design; D006801:Humans; D058990:Molecular Targeted Therapy; D009369:Neoplasms / Q000628:therapy*
chemical_list: D059451:Biosimilar Pharmaceuticals