Regulation and uptake of ‘similar biologics’ in India

Biosimilares/Investigación | Posted 11/12/2015 post-comment0 Post your comment

India has, by far, demonstrated the greatest acceptance of ‘similar biologics’. But what are the drivers and the limitations to the ‘similar biologics’ market in India? This is a question Dr Nagaraj Malipatil, a clinical pharmacologist, from Bangalore, India tried to address in his review of similar biologics in India [1].

Biologicals 4 V13L13

The Indian Department of Biotechnology (DBT) and Central Drugs Standard Control Organization (CDSCO) issued the ‘guidelines on similar biologics’ back in 2012. The guidelines were implemented from 15 September 2012. Prior to the introduction of the guidelines on similar biologics, these products were approved by the Review Committee on Genetic Manipulation (RCGM) and the CDSCO using an abbreviated version of the pathway applicable to new drugs on a case-by-case basis [2].

According to our research at GaBI Online, the first ‘similar biologic’ was approved and marketed in India for a hepatitis B vaccine in 2000. In recent years, over 50 biologicals have been approved for marketing in India, with more than half of them being similar biologics [3].

Factors facilitating the development and uptake of similar biologics in India, according to Dr Malipatil, include poor patent enforcement, less stringent regulatory requirements, low R & D costs, the low price of similar biologics and partnerships for the development of similar biologics for the Indian market and biosimilars for the global market.

However, restrictions to the uptake of similar biologics in India include the limited health insurance coverage in the country and concerns over the quality and safety of some domestically manufactured similar biologics.

In the following series of six articles just some of the issues related to similar biologics in India are presented.

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Related articles
Safety concerns limit similar biologics uptake in India

Lack of health insurance limits access to biologicals in India

Partnerships driving similar biologics development in India

Domestic biologicals cost less in India

Low costs and less stringent regulatory requirements in India

Factors affecting the uptake of ‘similar biologics’ in India

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.

1.    Malipatil NB, Haridas KM, Shruthi DP. Biosimilars and regulations: a review. J Pharm Biomed Sci. 2015;05(06):453-68.
2.    GaBI Online - Generics and Biosimilars Initiative. Indian guidelines for ‘similar biologics’ []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from:
3.    GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from:

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