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CDE publishes "Technical Guidelines for Clinical Pharmacology Research of Biosimilars"

 Last Update: 2022-03-08
 Source: Internet
 Author: User

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On February 11, CDE issued a notice on the "Technical Guidelines for Clinical Pharmacology Research of Biosimilars" (No.

In recent years, the research and development and application of biosimilars have been increasing

In order to further standardize and guide the development and evaluation of biosimilars, the guidelines are in the framework of the "Technical Guidelines for the Development and Evaluation of Biosimilars (Trial)" and the "Technical Guidelines for Similarity Evaluation and Indication Extrapolation of Biosimilars".

The biosimilars mentioned in this guideline refer to the therapeutic biological products that are similar to the registered reference drugs in terms of quality, safety and efficacy

According to the requirements of the "Notice of the General Department of the State Food and Drug Administration on Issuing the Procedures for Issuing the Technical Guiding Principles for Drugs" (Medical Administration Comprehensive Drug Administration [2020] No.

Attachment: Technical Guidelines for Clinical Pharmacology Research of Biosimilars.

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