Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, explains the value of interchangeability in the adalimumab space and predicts whether interchangeable biosimilars will become leaders in adoption.
Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, believes that adalimumab biosimilars will greatly impact the US health care system. However, whether interchangeable designations will affect the adoption of these products remains to be seen.
With states having different laws regarding interchangeability, new bills being introduced to Congress to eliminate switching study requirements, and only 4 biosimilars overall having an interchangeability designation, what is your view on the value of interchangeability?
Interchangeability introduces an additional cost. When the manufacturers are researching the medication during clinical trials, they are required to go through an additional step. And it's not just a little step; it's an extremely large step involving patients and clinical trials and millions and millions of dollars in additional costs to prove [basically] biosimilarity again, sort of. So, it's really kind of an extra step that's extremely costly, that is really just, again, proving that your medication is indeed the same thing as the reference product.
So I think the opinion that this is an extra, maybe unnecessary step is shared by many and that's why we're seeing these bills being introduced, and I think the bills make sense. They're very tactical. You know, “Here's what language we could remove from the 351(k) FDA approval pathway to kind of back that out and maybe simplify this process.” And not only simplify the process for manufacturers, but simplify the process for physicians, for prescribers, for pharmacists, and for the entire health care system.
Interestingly, for the one interchangeable biosimilar that we have in the adalimumab space today [Cyltezo], it is a higher-cost product. So I do believe that these additional clinical trials are unfortunately going to lead to higher costs being passed through to the product launch. And that's not really what any of us want to see. I love seeing these huge discounts that we're seeing on these new products with the low WAC [wholesale acquisition cost] strategies. And that's what we want to continue to see more of, and if we continue to add costs to the process to get the drug approved, it'll be more difficult for us to bring down this cost long term.
Do you think the interchangeable label will have an impact on adalimumab adoption or do you predict that adoption rates will be more like those in the interchangeable insulin space?
It's interesting; that's one of those kind of “predict the future” questions since we're still in early stages of this launch. However, Cardinal Health publishes a really nice biosimilars annual report, and we did publish one in 2023. And it did kind of clearly highlight that many providers prefer an interchangeability designation, in order to have a comfort level prescribing an adalimumab [biosimilar]. So even though we know this is a regulatory step, that is absolutely not a clinical designation. It's not a safety or efficacy designation; it's a regulatory designation only. Providers are being convinced that this may be a differentiator, and we do have some data supporting that—at least in the rheumatology space.
So will that impact market share? I think that will be determined in a lot of ways by the selections of the payers and the PBMs [pharmacy benefit managers] and the cost savings that's potentially passed to the patient. However, it's definitely not something that's going to hurt them at this particular point in time. I don't think that it is a bad thing to have interchangeability designation until we figure out as a country what we want to do with that longer term.