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为指导和规范生物类似药的研发与评价工作,推动生物医药行业健康发展,近日,国家食品药品监督管理总局发布《生物类似药研发与评价技术指导原则(试行)》,对生物类似药的申报程序、注册类别和申报资料等相关注册要求进行了规范。生物类似药是指在质量、安全性和有效性方面与已获准注册的参照药具有相似性的治疗用生物制品。由于生物类似药可以更好地满足公众对生物治疗产品的需求,有助于提高
In order to guide and standardize the research and evaluation of bio-similar drugs and promote the healthy development of the biomedicine industry, the State Food and Drug Administration recently released the Guiding Principles for R & D and Evaluation of Biologically Similar Drugs (for Trial Implementation) and the declaration of bio-analogs Procedures, registration categories and declarations and other relevant registration requirements for the specification. Biosimilars are therapeutic biologicals that are similar in quality, safety and efficacy to approved registered registries. Because biologics can better meet the public’s need for biotherapeutic products and help improve