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Suzette Kox, MPharm: Pharmacovigilance and Nonproprietary Names for Biosimilars


Suzette Kox, MPharm, Secretary General of the International Generic and Biosimilar Medicines Association (IGBA), discusses the European experience with using nonproprietary names for biosimilar pharmacovigilance.


It’s very straightforward: they can continue that policy. First, it is a scientific approach to allocate the same INN, international nonproprietary name, to the biosimilar and the reference product. That’s a scientific matter, that’s the first thing.

Secondly, we heard in the biosimilars conference today* again that there is a publication by European regulators and academics which has demonstrated that the identification of biologics—I think they looked into 10 different classes of biologics for which biosimilars exist—identification based on the INN and brand name is assured by 96.7%. So, it really works. And this will continue to work in the future.

*During the Medicines for Europe 17th Biosimilar Medicines Conference

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