One of the factors increasing the use of similar biologics in India is the fact that domestic biologicals cost much less than the originator brand-name biologicals [1].
Low development and manufacturing costs mean that domestic biologicals players are able to sell their products at a discount of 12–74% compared to the originator brand-name biological being sold in India, see Table 1.
Table 1: Prices of similar biologics compared to originator biologicals in India
| Biological
|
Discount to reference biological (%)
|
Average discount to brand-
name biologicals (%)
|
| epoetin
|
12-40
|
25
|
| filgrastim
|
16-29
|
23
|
| insulin glargine
|
38-43
|
40
|
| interferon alfa-2a
|
16-56
|
36
|
| interferon alfa-2b
|
44-55
|
49
|
| pegfilgrastim
|
36-74
|
55
|
| rituximab
|
38-47
|
42
|
Such huge discounts have, in some cases, forced manufacturers of originator biologicals to reduce their price in order to retain their market share. One such example is that of rituximab. Dr Reddy’s Laboratories (Dr Reddy’s) similar biologic Reditux (rituximab) was introduced in India in 2007 at 50% of the price of Roche’s originator biological Rituxan/MabThera (rituximab). In response, Roche lowered the price of Rituxan while promoting its brand-name product through various schemes in order to try to maintain its market share. Despite Roche’s efforts, in 2010–2011 domestic revenues from Reditux grew 75% making the product the fourth largest brand in Dr Reddy’s portfolio [2].
Such aggressive discounting may act as a deterrent for international players looking to launch similar biologics in India. This is especially true when comparing the fact that biosimilars in the EU and Japan are generally priced only 20–30% lower than the originator reference biological.
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. 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
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Lack of health insurance limits access to biologicals in India
Partnerships driving similar biologics development in India
Low costs and less stringent regulatory requirements in India
Factors affecting the uptake of ‘similar biologics’ 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. Dr Reddy’s plans EU launch for biosimilar rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 22]. Available from: www.gabionline.net/Biosimilars/News/Dr-Reddy-s-plans-EU-launch-for-biosimilar-rituximab
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