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 and the low price of similar biologics. Partnerships for the development of similar biologics for the Indian market and biosimilars for the global market are also facilitating the development of both similar biologics and biosimilars.

Poor patent enforcement in India provides opportunities for domestic biologicals manufacturers, while public–private sector partnerships promote similar biologics development. The less stringent regulatory requirements and low R & D costs enable domestic biologicals to be priced much lower in India compared to originator biologicals, further driving uptake as well as offering huge potential for contract manufacturing of biosimilars for the global market and for exports. Domestic companies are also entering into partnerships with international players to facilitate the development of similar biologics for the Indian market and biosimilars for global markets.

However, restrictions to the uptake of similar biologics in India include the limited health insurance coverage in the country. This means that despite the low price of similar biologics compared to originator biologicals, there is still poor access to biologicals in the country. Issues over the quality and safety of some domestically manufactured similar biologics also remain a concern among patients and physicians.

There are currently similar biologics of nine of the top 10 brand-name biologicals available in India; with similar biologics of bevacizumab in development, see Table 1.

Table 1: Status of similar biologics for top 10 biologicals

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

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 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

Regulation and uptake of ‘similar biologics’ in India

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