ECA新闻20150521：FDA生物类似物指南定稿（分享） - 药群论坛

In February 2009, the US Food and Drug Administration has published three draft guidance documents on the development of biosimilars. Now, on 15 April, the FDA issued the finalized version of these three documents:

在2009年2月，美国FDA公布了3个生物类似物研发的指南草案。现在，4月15日，FDA签发了这三个文件的最终版本。

1. "Scientific Considerations in Demonstrating Biosimilarity to a Reference Product" - provides guidance to companies which must demonstrate the boisimilarity of a therapeutic protein product to an existing reference product. The guidance recommends a stepwise risk-based "totality-of-the-evidence" approach to evaluate the biosimilarity to the reference product relating to structure, function, animal toxicity pharmacokinetics and pharmacodynamics, clinical immunogenicity, and clinical safety and effectiveness.

“证明与对照药物生物类似性的科学方面考量”---给公司提供了其必须证明一个蛋白治疗药品类似于已有的对照药物的指南。指南推荐了一个渐进式基于风险的“证据汇总”方式来评价与对照药物的与结构、功能、动物毒性药物动力学和药效学、临床免疫力和临床案例性与有效性相关的生物类似性。

2. "Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product" - This document comprises information about analytical factors and the importance of extensive analytical, physico-chemical and biological characterisation of a Biosimilar. These factors are unalienable to demonstrate high similarity to a reference product.

“证明与对照药物生物类似性的质量方面考量”---这份文件包括了关于生物类似物的分析要素和范围广泛的分析、理化和生物特性。这些是证明高度类似于对照药物不可或缺的要素。

3."Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 - This guidance provides answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA's interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The document classifies the Q&As in three different groups, relating to their content:

“生物类似物：关于实施2009年生物价格竞争和创新法案的问答”---该指南给出了来自一些对研发所提议的生物类似药物有兴趣的申报人、生物许可申报（BLA）持有人和其它对FDA的2009年生物价格竞争和创新法案（BPCI法案）解释有兴趣的各方的问题的答案。该文件将问答根据其内容分为三组：

These documents should assist industry in developing such biosimilar products in the United States and provide the FDA’s current thinking on key scientific and regulatory factors involved in submitting applications for biosimilar products to the agency. Through this approval pathway, biological products are approved based on demonstrating that they are biosimilar to / or interchangeable with a biological product that has already been approved by the FDA, which is called a reference product.

这些文件应协助美国企业开发这样的生物类似物药品，提供FDA目前关于向药监机构提交生物类似物申报资料的关键科学问题和法规要素的考虑。通过该批准途径，在证明这些生物类似药品类似于或可互换于一个已被FDA批准的生物药品（对照药品）的基础上，来获得批准。

These three documents are part of FDAs guidance series developed to implement the BPCI Act (Implementation of the Biologics Price Competition and Innovation Act of 2009). This series includes amongst the three ?guidance documents the guidelines for

这三个文件作为FDA指南系列的一部分，是建立用以实施BPCI法案的（2009年生物制品价格竞争和创新法案实施）。本系列包括有三个指南，内容包括：

The intention of these documents is to meet the demands of the requirements of Patient Protection and Affordable Care Act. They should establish a shorter and faster way for approval for Biosimilars under section 351(k).

这些文件的目的是满足《患者保护和平价医疗法案》的要求。它们应建立起一个更短更快的途径来批准根据351（k）的生物类似物。