Department of Medicine, University of California San Francisco Comprehensive Cancer Center, San Francisco, CA 94115, USA.
The US Oncology Network, The Woodlands, TX 77380, USA.
Future Oncol. 2019 Mar;15(7):777-790. doi: 10.2217/fon-2018-0680. Epub 2018 Nov 30.
Biologics are an integral component in the treatment of various diseases. However, limited patient access to these medicines remains a significant global challenge, prompting development of safe and effective biosimilars. A biosimilar is 'highly similar to a reference (originator) product, for which there are no clinically meaningful differences between the two products in terms of safety, purity and potency'. Biosimilars have the potential to offer possible benefits, including lower treatment costs, thereby increasing patient access and clinical use, which may lead to better overall outcomes. Improved understanding of biosimilars may enhance confidence and trust in these agents. As increasing numbers of biosimilars achieve regulatory approval, this overview aims to address enduring knowledge gaps regarding the development and use of biosimilars.
生物制剂是治疗各种疾病的重要组成部分。然而，患者获得这些药物的机会有限仍然是一个全球性的重大挑战，促使开发安全有效的生物类似药。生物类似药是“与参照（原创）产品高度相似，在安全性、纯度和效力方面，两者之间不存在临床意义上的差异”。生物类似药具有提供可能益处的潜力，包括降低治疗成本，从而增加患者的可及性和临床应用，这可能会带来更好的总体结果。对生物类似药的认识不断提高，可能会增强对这些药物的信心和信任。随着越来越多的生物类似药获得监管批准，这一综述旨在解决关于生物类似药的开发和使用方面持续存在的知识空白。
