Suzette Kox, MPharm: 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.