Guidelines on Similar Biologics – Regulatory Requirements for Marketing Authorization in India 2016

The Guidelines on Similar Biologics prepared by Central Drugs Standard Control Organization (CDSCO) and the DBT lay down the regulatory pathway for a Similar Biologic claiming to be similar to an already authorized reference biologic.

• A similar biologic product is one which is similar in terms of quality, safety and efficacy to an approved reference biological product based on comparability.
• The guidelines address the regulatory pathway regarding manufacturing processes and safety, efficacy and quality aspects for similar biologics, pre-market regulatory requirements and post-market regulatory requirements for similar biologics.