Need for a global pathway for biosimilars

Biosimilars/Research | Posted 06/06/2011 post-comment0 Post your comment

The need for access to biosimilars is global, yet the regulations are national. Issues with this approach are discussed by Dr Mark McCamish and Dr Gillian Woollett in their published paper [1].


Biosimilars are recognised around the world as safe and effective medicines. The WHO has also released guidelines, based on those of the EU, as well as other regulated markets, such as Australia, Canada and Japan. These aim to assist less regulated markets with approval of biosimilars.

However, regulations for the approval of biosimilars remain country/region-specific. The main issue is that each region requires a reference product which has already been approved in that region. Therefore, for example, in the EU, biosimilar manufacturers are required to compare their product to a reference product approved by the EMA in Europe. Likewise for the US, a FDA approved reference product would be required.

This thus requires duplication of the clinical development in each region, which vastly increases the costs entailed to get a biosimilar to market. This is also the case even when the reference product is made at a single facility for worldwide use.

The authors suggest that data showing that region-specific reference products are indistinguishable and should be acceptable to enable a global dossier for a potential biosimilar to be produced.

Related articles

Interchangeability or substitution of biosimilars

Regulatory approach to biosimilar development

Opportunities for biosimilar development

Comparability for biosimilar development

Worldwide biosimilar development

Global biosimilar market to grow to US$3.7 billion in 2015

US guidelines for biosimilars

US healthcare reform


1. McCamish M, Woollett G. Worldwide experience with biosimilar development. mAbs. 2011;3(2):209-17. doi:10.4161/mabs.3.2.15005

comment icon Comments (0)
Post your comment
Related content
Regulatory landscape for biosimilars in Latin America
Latin America 1638px
Biosimilars/Research Posted 09/09/2022
Totality of evidence for biosimilar pegfilgrastim Ziextenzo
Pegfilgrastim V16B19
Biosimilars/Research Posted 09/09/2022
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010