Biosimilar Integration into PNH Treatment Landscape

EP: 1.Phase III Apply-PNH Study Overview

EP: 2.Selecting Optimal Treatment Therapies for PNH

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EP: 3.Biosimilar Integration into PNH Treatment Landscape

EP: 4.Cost Utilization Analysis in PNH Treatment Pathways

EP: 5.Unmet Needs Surrounding PNH

Carlos M. De Castro, MD: There was a presentation on a biosimilar that has letters and numbers, ABP 959, which is basically a biosimilar to eculizumab. The data were compelling in that it looks nearly equivalent to eculizumab in the patients they tested it on. It was a small study, but it effectively brought LDH [lactate dehydrogenase] levels down, showing that you’re blocking hemolysis. It seems safe and very efficacious. There was, I believe, some antibody detection against the drug, but none that were leading to the inactivation of the drug. The problem I had with the study is you’re making a biosimilar to a drug that we are not using much anymore, with the exception of pregnancy. And this drug won’t have that kind of pregnancy data with it. Eculizumab, because it has to be given every 2 weeks, at least in this country where ravulizumab is available—and ravulizumab is basically the same antibody just altered so it lasts in the circulation longer and gives better levels—I think more of us are using ravulizumab than eculizumab. Where this drug is going to fit in then, even if it’s a biosimilar and it can bring costs down, it’s going to be difficult. I don’t think patients are going to want to go back to every-2-week treatments if they’ve been on every-8-week treatments.

We use biosimilars a lot, especially in terms of growth factors, such as G-CSF [granulocyte colony-stimulating factor] or filgrastim, which we used to use a lot of. There are many biosimilars now that we are using, rather than the initial drug. They seem to be equivalent, that’s the bottom line. So, it’s a matter of economics now as to which one’s cheaper to use.

I can see where insurance companies would say, “No, we’re not paying for that drug, we’re going to pay for this drug.” And that would cause issues because, again, I think patients are going to realize, “Wait a minute, there’s a drug out there that’s given every 8 weeks. I don’t want to be taking one every 2 weeks.” So, there would be pressure back and forth to see what would happen. I’m not sure who would win that battle.

I think this is an interesting drug. I wish we had a biosimilar for some of the other ones, and then we could bring the cost down for everything. But that’s a long way away since these drugs are new and will have exclusivity for a while.

Transcript edited for clarity.