Factors affecting the uptake of ‘similar biologics’ in India

In his review of similar biologics in India, Dr Nagaraj Malipatil, a clinical pharmacologist from Bangalore, attempted to address what are the drivers and the limitations to the ‘similar biologics’ market in India [1].

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

Brand-name	Active substance	Originator company	2014 global sales US$	Status of similar biologic
Humira	adalimumab	AbbVie	12.5	Launched 2014 [2]
Remicade	infliximab	Johnson & Johnson	9.3	Launched 2014 [3]
Enbrel	etanercept	Amgen/Pfizer	8.3	Launched 2013 [4]
Avastin	bevacizumab	Roche	7.4 [5]	Undergoing preclinical studies
Lantus	insulin glargine	Sanofi	6.8	Launched in 2009 [6]
Herceptin	trastuzumab	Roche	6.2	Launched in 2013 [7]
Neulasta	pegfilgrastim	Amgen	5.8	Launched in 2007 [8]
Rituxan	rituximab	Roche	5.5	Launched in 2007 [9]
Epogen	epoetin alfa	Amgen	3.2	Launched in 2001 [10]
Aranesp	darbepoetin alfa	Amgen	1.9	Launched in 2010 [11]

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.

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

References
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. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
3.    GaBI Online - Generics and Biosimilars Initiative. Biosimilars of infliximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-infliximab
4.    GaBI Online - Generics and Biosimilars Initiative. Biosimilars of etanercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-etanercept
5.    GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
6.    GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
7.    GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab
8.    GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim
9.    GaBI Online - Generics and Biosimilars Initiative. Biosimilars of rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-rituximab
10.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars of epoetin alfa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-epoetin-alfa
11.   GaBI Online - Generics and Biosimilars Initiative. Biosimilars of darbepoetin alfa [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 8]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-darbepoetin-alfa

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Safety concerns limit similar biologics uptake in India