Biosimilar guidelines and regulations are being developed all over the world, as outlined by Huiguo Hu at the Biosimilars Europe Congress [1].
The European Union (EU) was the first to introduce guidelines for biosimilars back in 2005 [2]. But since then many countries and regions have introduced regulations specific to biosimilars, see Table 1.
Table 1: Global biosimilar guidelines (2005-2015)
| Country/region
|
Year of regulation launched
|
Comparative clinical trials required
|
| Argentina
|
2011 [2]
|
Yes
|
| Australia
|
2013 [3]
|
Yes
|
| Brazil
|
2010 [4]
|
Yes
|
| Canada
|
2010 [5]
|
Yes
|
| China
|
2015 [6]
|
Yes (local)
|
| Colombia
|
2013 [2]
|
Yes
|
| Cuba
|
2011
|
Yes
|
| Egypt
|
2012 [7]
|
Yes
|
| European Union
|
2005 [8]
|
Yes
|
| India
|
2012 [9]
|
Yes (local)
|
| Iran
|
2014 [10]
|
|
| Japan
|
2009 [11]
|
Yes
|
| Jordan
|
2012
|
Yes
|
| Malaysia
|
2008 [2]
|
Yes
|
| Mexico
|
2011 [12]
|
Yes
|
| Nigeria
|
2012 [13]
|
|
| Peru
|
2011
|
|
| Russia
|
2014
|
Yes (local)
|
| Saudi Arabia
|
2010 [2]
|
Yes
|
| Singapore
|
2009 [14]
|
Yes
|
| South Africa
|
2010
|
Yes
|
| South Korea
|
2009 [15]
|
Yes
|
| Taiwan
|
2008 [2]
|
Yes
|
| Thailand
|
2012
|
Yes
|
| Turkey
|
2008 [16]
|
Yes
|
| USA
|
2010 [17]
|
Yes
|
| Venezuela
|
2012 [18]
|
|
| WHO (World Health Organization)
|
2009 [19]
|
Yes
|
Many of the countries that have introduced regulations for biosimilars are ‘emerging markets’ developing biosimilars. In these markets/regions biosimilars are often less regulated or even unregulated and are thus referred to as ‘non-originator biologicals’ [20].
Taking into account the huge cost of originator biologicals, and with the growing affluence and purchasing power in these developing countries, the market for non-originator biologicals is expected to grow significantly in these regions for the foreseeable future. Although exact figures are hard to obtain, some estimate that the market size for non-originator biologicals in emerging regions may soon become equivalent or larger than the EU/US biologicals market size [21].
Editor’s comment
It should be noted that ‘non-originator biologicals’ approved outside Europe 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.
References
1. Hu H. Challenges & strategies to enter the emerging markets for biosimilars. Biosimilars Europe Congress. 22-23 November 2016, London, UK.
2. García Cortes JA, Sierra Esteban FJ. Regulations for biotherapeutics approval in Colombia. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):26-8. doi:10.5639/gabij.2018.0701.006
3. GaBI Online - Generics and Biosimilars Initiative. Australian guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/Australian-guidelines-for-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Brazilian guidelines for follow-on biological products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/Brazilian-guidelines-for-follow-on-biological-products
5. GaBI Online - Generics and Biosimilars Initiative. Canadian guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/Canadian-guidelines-for-biosimilars
6. GaBI Online - Generics and Biosimilars Initiative. Chinese guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/Chinese-guidelines-for-biosimilars
7. GaBI Online - Generics and Biosimilars Initiative. Egypt issues draft guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/Egypt-issues-draft-guidelines-for-biosimilars
8. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars
9. GaBI Online - Generics and Biosimilars Initiative. Indian guidelines for ‘similar biologics’ [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/Indian-guidelines-for-similar-biologics
10. GaBI Online - Generics and Biosimilars Initiative. Iranian guidelines for ‘biogenerics’ [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/Iranian-guidelines-for-biogenerics
11. GaBI Online - Generics and Biosimilars Initiative. Japanese guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/Japanese-guidelines-for-biosimilars
12. GaBI Online - Generics and Biosimilars Initiative. Mexican guidelines for biocomparables [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/Mexican-guidelines-for-biocomparables
13. GaBI Online - Generics and Biosimilars Initiative. Nigerian guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/Nigerian-guidelines-for-biosimilars
14. GaBI Online - Generics and Biosimilars Initiative. Singapore guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/Singapore-guidelines-for-biosimilars
15. GaBI Online - Generics and Biosimilars Initiative. South Korean guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/South-Korean-guidelines-for-biosimilars
16. GaBI Online - Generics and Biosimilars Initiative. Turkish guidelines for follow-on biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/Turkish-guidelines-for-biosimilars
17. GaBI Online - Generics and Biosimilars Initiative. US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimilars
18. GaBI Online - Generics and Biosimilars Initiative. Venezuela issues draft guideline for bioterapéuticos similares [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/Venezuela-issues-draft-guideline-for-bioterapeuticos-similares
19. GaBI Online - Generics and Biosimilars Initiative. Global guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Guidelines/Global-guidelines-for-biosimilars
20. GaBI Online - Generics and Biosimilars Initiative. Biosimilars in emerging markets [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Reports/Biosimilars-in-emerging-markets
21. GaBI Online - Generics and Biosimilars Initiative. Global uptake of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Apr 13]. Available from: www.gabionline.net/Reports/Global-uptake-of-biosimilars
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