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These guidelines address the regulatory pathway regarding manufacturing process and safety, efficacy and quality aspects for Similar Biologics.

These guidelines also address the pre-market regulatory requirements including comparability exercise for quality, preclinical and clinical studies and post market regulatory requirements for Similar Biologics.

These guidelines are for the guidance of all stakeholders and are not meant to substitute or
rephrase the Rules made under Drugs and Cosmetics Act, 1940 or any other relevant Acts
and are subject to being in conformity with the Drugs and Cosmetics Act and Rules as may be amended from time to time.

To Download the Biosimilar 2016 Guidelines Follow the below link
https://cdsco.gov.in/opencms/opencms/sy ... d=NTU0NA==

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