Center for Autoimmune Diseases Research (CREA), School of Medicine & Health Sciences, Universidad del Rosario, Carrera 24 # 63-C-69. Third Floor, Bogotá, Colombia.
Immunotherapy. 2012 Dec;4(12):1841-57. doi: 10.2217/imt.12.128.
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.
生物治疗产品（BPs）彻底改变了医学，改变了我们治疗多种疾病的方式，如自身免疫性疾病和癌症等。本文介绍了类似的生物治疗产品（SBPs），也称为生物仿制药，包括制造过程和涉及的监管方面。开发 SBP 的目的是通过进行可比性研究（CE）来制造一种与参比生物制剂高度相似的分子，以证明其具有相似的安全性和疗效。该 CE 包括质量以及非临床和临床评估。基于科学和客观标准的个案分析方法必须成为 SBP 审批程序的基础。在全面的 SBPs 和参比 BPs 的 CE 之间建立平衡，并设计具有成本效益的策略，以更好地获得生物制剂，这应该是国家监管机构的主要目标。
