Knezevic Ivana
Department of Immunization, Vaccines and Biologicals, Quality, Safety and Standards Team, World Health Organization, Avenue Appia, Geneva, Switzerland.
Biologicals. 2011 Sep;39(5):256-61. doi: 10.1016/j.biologicals.2011.08.008. Epub 2011 Sep 9.
The availability of biotherapeutic products to patients has a major impact on the success in treating many life-threatening and chronic diseases. These products are often derived by recombinant DNA technology and are expensive for the majority of patients who need them most. Increasing numbers of patents/data protection are now expiring and biologicals "similar" to the originators (innovative products) are coming to the market. This process is seen as a mechanism for increasing the access to biotherapeutic products which are very much needed for the treatment of chronic diseases worldwide. The emergence of Similar Biological Products (SBPs) has created numerous challenges in developing, licensing, and using these important products. From a public health perspective, the overall expectation is that similar products will be available at an affordable price and will increase patients' access to the therapy. In response to the requests for assistance in defining regulatory requirements for SBPs, the WHO Expert Committee on Biological Standardization (ECBS) adopted the new WHO Guidelines for evaluation of SBPs in October 2009. This article provides a brief account of the WHO initiative to assist its member states to establish national requirements for the regulatory oversight of SBPs. The aim of the article is to inform its readers of the current status of WHO Guidelines on the evaluation of similar biotherapeutic products and of the plan to strengthen national regulatory requirements to assure quality, safety and efficacy of similar biotherapeutic products at the global level.
生物治疗产品能否提供给患者，对治疗许多危及生命的疾病和慢性病的成效有着重大影响。这些产品通常通过重组DNA技术生产，对于最需要它们的大多数患者来说价格昂贵。现在，越来越多的专利/数据保护即将到期，与原创产品（创新产品）“相似”的生物制品正在进入市场。这一过程被视为增加生物治疗产品可及性的一种机制，而生物治疗产品是全球治疗慢性病急需的。相似生物制品（SBP）的出现给这些重要产品的研发、许可和使用带来了诸多挑战。从公共卫生角度来看，总体期望是相似产品将以可承受的价格供应，从而增加患者获得治疗的机会。为回应在界定SBP监管要求方面的援助请求，世界卫生组织生物标准化专家委员会（ECBS）于2009年10月通过了新的《世界卫生组织相似生物制品评估指南》。本文简要介绍了世卫组织协助其成员国制定SBP监管国家要求的举措。本文旨在向读者通报世界卫生组织相似生物治疗产品评估指南的现状，以及加强国家监管要求以确保全球层面相似生物治疗产品质量、安全性和有效性的计划。
