India updates its similar biologics guidelines

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The Indian Ministry of Health has revised its guidelines for approving ‘similar biologics’. The guideline was updated in order to make the regulatory pathway more robust and to align the guidelines further with global guidelines for biosimilars. The update was seen as essential in order to meet the ‘ever changing global standards’.

India V13C03

The updated Indian guidelines on similar biologics became effective on 15 August 2016. The new guideline replaces the previous guideline of 15 September 2012. Prior to the introduction of the first guideline such products were approved by the Review Committee on Genetic Manipulation (RCGM) and the Central Drugs Standard Control Organization (CDSCO – under the Ministry of Health and Family Welfare) using an abbreviated version of the pathway applicable to new drugs on a case-by-case basis [1].

In this new updated version of the Indian guidelines the Department of Biotechnology (DBT) still states that a ‘case-by-case examination is important’. However, the agency also says that these guidelines provide ‘clarity’ and also reinforce the need for data ‘proving the similarity, physicochemical characterization, preclinical studies and clinical trials’.

Guidelines on similar biologics
Effective Date: 15 August 2016

The revised guidelines increase requirements in areas such as comparability testing with the reference drug. For example, the guideline states that ‘the similar biologics manufacturer should develop the manufacturing process to yield a comparable quality product in terms of identity, purity and potency to the reference biologic’.

The guideline also specifies that, as part of the post-marketing (phase IV) studies, a ‘pre-defined single arm study of generally, more than 200 evaluable patients’ should be completed within two years of marketing authorization and should also be ‘compared to historical data of the reference biologic’. It also adds that ‘the phase IV protocol should be submitted along with marketing authorization application for approval’.

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
‘Similar biologics’ approved and marketed in India

1. GaBI Online - Generics and Biosimilars Initiative. Indian guidelines for ‘similar biologics’ []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 10]. Available from:

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Source: CDSCO

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