Guidelines for biosimilars around the world Posted 13/04/2018

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 biosimilars [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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