Suzette Kox, MPharm: Global Reference Products in Biosimilar Development

June 13, 2019

Suzette Kox, MPharm, Secretary General of the International Generic and Biosimilar Medicines Association (IGBA), discusses progress made toward the use of global reference products in biosimilar development.

Transcript

I’m quite optimistic on that. Why I’m optimistic is because the [World Health Organization, WHO] at the moment works on the pilot prequalification process for trastuzumab and for rituximab.

What does it mean in practice? If, for example, a trastuzumab is approved, is prequalified by the WHO, that could be, for example, a US-approved product or a biosimilar, or a European biosimilar, they have used a comparator in biosimilar development, but the product itself will be used around the world where it has been part of [United Nations, UN] tender or governments want to have access to that prequalified product. Automatically, that comparator, which has been used in the biosimilar development, becomes a global comparator product.

I think we will take that up with the WHO once that process is completed so that we get a list of comparator products which can be used for biosimilar development. They have defined that already in their procedure itself, so I think that’s very promising, because we are really here in the practice, and we can build on that.

Furthermore, we have identified that a number of countries around the world accept, already, a foreign comparator product in biosimilar development which is representative of their reference product. As IGBA, we are for the moment working on a positive list of those countries, and we will make that public once that task is completed. So I’m quite positive on those developments.

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