Comparison of biosimilars guidelines

Generics and Biosimilars Initiative Journal (GaBI Journal). 2014;3(1):36-8.
DOI: 10.5639/gabij.2014.0401.012

Published in: Volume 3 / Year 2014 / Issue 1
Category: Regulatory
Page: 36-8
Visits: 27912 total, 3 today
Keywords: biosimilars, Canada, EU, guidelines, Japan, Korea, regulation, WHO

This paper provides a detailed comparison of biosimilars guidelines issued in Canada, the European Union, Japan and Korea; and by the World Health Organization (WHO). This comparison highlights the need for harmonization of global regulatory standards for the approval of biosimilars.

Biosimilars are recognized around the world as safe and effective medicines. Despite this fact, they are still relatively new to most countries and make up only a small part of the biologicals market. The growing demand for ‘life-changing’ biologicals, however, is fuelling their growth.

Regulatory guidelines and standards for biosimilars have been introduced around the world but are still being developed in some countries. The clarity of these guidelines, however, is variable and the regulatory pathways are diverse, with even agreement on how to define biosimilars differing sometimes significantly between different countries and regions. Guidelines for biosimilars are constantly evolving as technology develops, but how do these guidelines differ in different regions? In this paper, biosimilars guidelines in some of the major countries/regions around the world are compared.

Europe is by far the most advanced in the regulation of biosimilars, and has the best-established framework for approval of biosimilars, being the first to create guidelines for these products. In the European Union (EU), a legal framework for approving biosimilars was established in 2003. The regulatory body for the approval of medicines in the EU is the European Medicines Agency (EMA). EMA issued its first guideline for the approval of biosimilars via an abbreviated registration process in 2005 and has since developed many general and specific guidelines for biosimilars [1].

Biosimilars regulations in Japan were issued by Japan’s regulatory authority, the Ministry for Health Labour and Welfare (MHLW), in March 2009 and follow the principles of the EU biosimilars regulations [24]. The Korean Food and Drug Administration (KFDA) issued a guideline regarding the regulation of biosimilar products (Guideline on Evaluation of Biosimilar Products) in July 2009 [5]. Health Canada finalized guidelines for subsequent entry biologics (SEBs) in March 2010 [6]. While global guidelines on similar biotherapeutic products were adopted by the WHO Expert Committee on Biological Standardization at its 60th meeting in October 2009 [7].

How guidelines for biosimilars compare around the world (Canada, EU, Japan, Korea and WHO) is shown in Table 1.

Table 1 shows that there are many similarities between the different countries/regions in their approach to guidelines for biosimilars. The guidelines are all based on the fact that biosimilars are intended to be used at the same dose(s) and dosing regimen(s) as the reference product. They all focus on the demonstration of (bio)similarity not individual patient benefit. All the guidelines also require an extensive comparability exercise to be carried out to ensure similar quality, safety and efficacy. The scientific principles underlying the comparability exercise required for a biosimilar are the same as that required for changes in the manufacturing process of an originator biological. Similar physicochemical characteristics are a prerequisite for reduction in non-clinical and clinical data requirements, i.e. use of the abbreviated biosimilars pathway.

The harmonization of regulatory standards for biosimilars would be of great advantage to biosimilars manufacturers. This would enable them to reduce costs and create a level playing field for manufacturers from different countries/regions. The development of a global reference product would also be of a great advantage, allowing manufacturers to reduce the number of trials required for global approval.

Global guidelines for the development of biosimilars need to be scientifically sound and in accordance with recognized strict regulatory standards, such as those of the EU and WHO. On the other hand, they also need to be flexible enough to account for differences in national regulations and market capabilities.

Competing interests: None.

Provenance and peer review: Article prepared based on extensive research; internally peer reviewed.

Michelle Derbyshire, PhD, GaBI Online Editor

1. Blank T, et al. Safety and toxicity of biosimilars—EU versus US regulation. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(3):144-50. doi:10.5639/gabij.2013.0203.039
2. Arato T. Regulatory guidelines for biosimilars in Japan. 10th EGA International Symposium on Biosimilar Medicines; 2012 April 20; London, UK.
3. Derbyshire M. Biosimilar development and regulation in Japan. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(4):207-8. doi:10.5639/gabij.2013.0204.055
4. GaBI Online – Generics and Biosimilars Initiative. Japanese guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 12]. Available from:
5. GaBI Online – Generics and Biosimilars Initiative. South Korean guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 12]. Available from:
6. GaBI Online – Generics and Biosimilars Initiative. Canadian guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 12]. Available from:
7. GaBI Online – Generics and Biosimilars Initiative. Global guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Nov 12]. Available from:

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