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生物技术产业是中国政府确定的七大战略性新兴产业之一。近年来生物技术药物在国内外得到了迅猛发展。为了适应生物技术药物的发展,欧盟和美国先后出台生物类似物的相关政策。美国在生物类似物研究及监管政策制定方面具有一定的特点,本文重点介绍了美国生物类似物监管法规及其建立背景、生物类似物相关指南以及指南指定过程中重点考虑的问题、FDA在生物类似物方面所面临的挑战,希望对我国生物制品的研究以及相关政策的制定提供参考。
The biotechnology industry is one of the seven strategic emerging industries identified by the Chinese government. In recent years, biotech drugs have enjoyed rapid development both at home and abroad. In order to adapt to the development of biotechnology drugs, the European Union and the United States have introduced biological analogs related policies. The United States has certain characteristics in the development of biological analogues and regulatory policies. This article focuses on the regulatory framework of the U.S. biological analogues and their setting-up background, guidelines for biological analogs and key considerations in the guideline design process. We hope to provide reference for the research of biological products in our country and the formulation of relevant policies.