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Law, Regulation or Guideline
Record information and status
Record ID
Date of creation
2019-02-28 12:06 UTC (sujata@nic.in)
Date of publication
2019-02-28 12:06 UTC (sujata@nic.in)

General Information
  • India
Title of document
Guidelines on Similar Biologics
Legislative details
Type of document
  • National Guideline
Subject areas
  • Contained use
  • Human and/or Animal Health
  • Pharmaceuticals
  • Biologics
Types of LMOs addressed
  • Biologics or Biosimilars
Brief description of the document including objective and scope:
The "Guidelines on Similar Biologics" prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) lay down the regulatory pathway for a similar biologic claiming to be similar to an already authorized reference biologic . The guidelines address the regulatory pathway regarding manufacturing process 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.
Document details
Document text
Guidelines on Similar Biologics.pdf (4 MB)
Guidelines on Similar Biologics
Regulatory contact information
Contact person
Dr Sujata Arora
2nd Floor, Vayu Block, Indira Paryavaran Bhawan, Jorbagh
New Delhi, Delhi
India, 110003
Additional Information
Other relevant website address or attached documents