许多国家已经建立了生物类似药的审批途径,因为建立明确的生物类似药上市审批途径,既保证患者能及时得到这些生物制品,又能确保这些生物制品的质量、有效性和安全性。本文对欧盟、美国和中国生物类似药法规情况进行梳理,希望能对中国生物类似药的研发具有借鉴意义。 Many countries have established biosimilar drug approval channels because of the establishment of a clear bio-drug listing approval approach, both to ensure that patients can get these biological products in a timely manner, but also ensure the quality, effectiveness and safety of these biological products. This article sorts out the biosafety regulations in the EU, the United States and China and hopes to provide reference for the research and development of biologically-based drugs in China.