Suzette Kox, MPharm, secretary general of the International Generic and Biosimilar Medicines Association (IGBA), discusses the need to waive bridging studies in biosimilar development.
We need to make really substantial progress on waiving of bridging studies where the comparator products used are just another version of the local reference product.
So how are we going to do that? I think we have of course the excellent publication of Christopher J. Webster and Gillian R. Woollett, DPhil, which has laid the scientific basis for this reflection that eventually we have only 1 comparator product on the market, which should be the basis for the biosimilar development. That’s one thing.
But how do we get this forward? Because the science is there, because these products are based on the same clinical data package, even versions which are on the market around the world. I think what we are probably going to do is of course we’ve had some interaction with some agencies. We’ll further talk about it at different conferences to get the ball rolling, keep the momentum.
It should be a key priority for the [IPRP, the International Pharmaceutical Regulators Program], there is a biosimilar working party, and the IPRP (it was formerly IPRF); this is for me the largest forum for the moment where biosimilars are discussed, and it should be a key priority to look into that.