Interchangeability or substitution of biosimilars

Biosimilars/Research | Posted 27/05/2011 post-comment0 Post your comment

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].


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.

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

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