Guidelines on Similar Biologics

The “Guidelines on Similar Biologics” prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) laying down the regulatory pathway for a biologic claiming to be Similar to an already authorized Reference Biologic have been published.

The objective of the guidelines is to provide guidance to the applicants to enable them to understand and comply with the regulatory requirements for market authorization of Similar Biologics in India.

Stay glued for more updates on this!

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One thought on “Guidelines on Similar Biologics

  1. Pingback: Guidelines on Similar Biologics published – Anand and Anand Blog

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