The interchangeability or substitution of biosimilars is a subject that differs somewhat between Europe and the US. These different approaches to biosimilars are discussed by Dr Mark McCamish and Dr Gillian Woollett in their published paper [1].
Interchangeability or substitution of biosimilars
Biosimilars/Research | Posted 27/05/2011 0 Post your comment
In the EU, EMA does not have the authority to designate biosimilars as being interchangeable with the reference product.
In the US, however, the Biologics Price Competition and Innovation Act gives the FDA the authority to designate a biosimilar as interchangeable with its reference product. This means that the biosimilar may be substituted for the originator product by the pharmacist without reference to the prescribing physician.
This automatic substitution, the authors feel, would enable biosimilars to be adopted much more rapidly. Thus increasing access for patients to these often life-changing medicines and reducing healthcare costs for both patients and governments.
According to Dr McCamish and Dr Woollett, a biosimilar product for which comparability is demonstrated should be interchangeable with its comparator, as is the case for conventional generics.
Related articles
Need for a global pathway for 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
Reference
1. McCamish M, Woollett G. Worldwide experience with biosimilar development. mAbs. 2011;3(2):209-17. doi:10.4161/mabs.3.2.15005
News
First denosumab biosimilars approved in Canada and the US
Dr Reddy's launches bevacizumab biosimilar Versavo in the UK
General
Brazil advances in follow-on biologicals/biosimilars approvals, trailing Europe
Insurer perspective on increasing biosimilar uptake in Canada
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Related content
Comparing biosimilar adoption: Medicare Advantage versus traditional Medicare
Questioning the need for ethnic sensitivity assessments for biosimilar monoclonal antibodies
ANVISA's role in biosimilar medicine regulation and innovation promotion
Infliximab discontinuation in patients with originator retransition vs biosimilar continuation
Comments (0)
Post your comment