In order to guide and standardize the research and development and evaluation of biosimilar drugs and promote the healthy development of the biomedical industry, the State Food and Drug Administration recently issued the "Technical Guidelines for the Development and Evaluation of Biosimilars (Trial)" (hereinafter referred to as the "Guiding Principles" ), which regulates the relevant registration requirements such as the application procedures, registration categories and application materials of biosimilar drugs.

　　 Biosimilar drugs refer to therapeutic biological products that are similar in quality, safety and effectiveness to the reference drugs that have been approved for registration. Since biosimilar drugs can better meet the public's demand for biotherapeutic products, and help increase the availability of biologic drugs and reduce prices, many countries attach great importance to the research and development and management of biosimilar drugs, and there are more than 20 in the world. Countries or organizations have developed guidelines for biosimilars.

In response to the strong desire of domestic and foreign drug manufacturers to develop biosimilar drugs in China, in order to promote the healthy and orderly development of China’s biopharmaceutical industry, the State Food and Drug Administration promptly organized the Drug Evaluation Center and other technical departments to learn from the World Health Organization On the basis of relevant domestic and foreign guidelines and successful research and development cases of international biosimilar drugs, we fully solicit and listen to the opinions of industry experts and companies, and combine the actual situation and specific national conditions of China’s biopharmaceutical research and development to ensure that biosimilar drugs and original research The principle of similarity, and at the same time can reduce the company's research and development time and cost, completed the drafting of the "Guiding Principles".

　　 The "Guiding Principles" clarify the definition of biosimilar drugs, put forward the basic principles for the development and evaluation of biosimilar drugs, and put forward specific requirements for the pharmaceutical, non-clinical and clinical research and evaluation of biosimilar drugs. The issuance of the "Guiding Principles" signifies that my country has basic principles to follow for the evaluation and management of biosimilar drugs, and has laid a good foundation for further standardizing the research and development of such drugs and improving their safety, effectiveness and quality control. basis. The State Food and Drug Administration will make timely amendments and improvements in accordance with new situations and new problems that have emerged during the trial implementation of the "Guiding Principles", and further refine the relevant evaluation standards and requirements to better encourage the development of high-level and high-quality biosimilar drugs , To promote the healthy development of my country's biopharmaceutical industry.