Announcement of the Center for Drug Evaluation of the National Food and Drug Administration on Issuing the Technical Guidelines for Similarity Evaluation and Indication Extrapolation of Biosimilar Dru
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In order to further standardize and guide the research and development and evaluation of biosimilars, and provide technical reference for industry, researchers and regulatory agencies, the Center for Drug Evaluation has formulated the "Technical Guidelines for the Evaluation of Similarity and Indication Extrapolation of Biologicalsimilars" (see attachment) . In accordance with the requirements of the "Notice of the General Department of the State Drug Administration on Issuing the Procedures for Issuing the Technical Guidelines for Drugs" (Yao Jian Zong Yao Guan [2020] No. 9), it is hereby issued upon review and approval by the State Drug Administration, as of the date of issuance From implementation.
announce.
Drug Evaluation Center of the State Drug Administration
February 10, 2021
Attachment 1: "Technical Guidelines for the Evaluation of Similarity of Biosimilar Drugs and the Extrapolation of Indications".pdf 
