India releases revised guidelines for ‘similar biologics’

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On 26 March 2016, India’s Central Drugs Standard Control Organization (CDSCO) announced the release of proposed revised guidance for ‘similar biologics’ in India.

India-Biotech Dept V13K29

India released draft guidelines on ‘similar biologics’ for the first time at the BIO Industry Conference on 19 June 2012 in Boston, USA [1], and the finalized guidelines were implemented from 15 September 2012 [2].

The regulatory bodies responsible for approval of ‘similar biologics’ in India are the Department of Biotechnology (DBT – under the Ministry of Science and Technology), through its Review Committee on Genetic Manipulation (RCGM), and the CDSCO (under the Ministry of Health and Family Welfare).

According to the CDSCO, at present several organizations are actively engaged in manufacturing and marketing ‘similar biologics’ in India. So far, these ‘similar biologics’ were approved by RCGM and CDSCO using an abbreviated version of the pathway applicable to new drugs on a case-by-case basis. Since there are several such products under development in India, both regulatory agencies considered the need to publish a clear regulatory pathway outlining the requirements to ensure comparable safety, efficacy and quality of a ‘similar biologic’ to an authorized reference biological. Based on demonstration of similarity in the comparative assessment, a ‘similar biologic’ may require reduced preclinical and clinical data package as part of submission for market authorization.

Guidelines on similar biologic
Date: 26 March 2016
End of consultation (deadline for comments): 30 April 2016

A ‘similar biologic’ can only be developed against an authorized reference biological that has been approved using a complete data package in India. However, one change in the revised guideline is that in cases where the reference biological is not authorized in India, it should have been approved/licensed and marketed in an ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) country. This replaces the previous requirement of ‘it should have been licensed and marketed for at least four years with significant safety and efficacy data’.

Another important addition is that the ‘similar biologic’ must now meet acceptable levels of safety, efficacy and quality to ensure public health in accordance with international guidelines (WHO 2013).

The draft revised guideline is available on the CDSCO website and open for comments until 30 April 2016.

Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Related article
India to revise ‘similar biologics’ guideline

1. GaBI Online - Generics and Biosimilars Initiative. India releases draft ‘similar biologic’ guidelines []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Indian guidelines for ‘similar biologics’ []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from:

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Source: CDSCO

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