Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, discusses what the future biosimilars marketplace may look like compared with generics and reference products at Asembia 2023.
Although a "generic-like" model may be preferable to stakeholders, the United States has a long way to go to get the biosimilars market to reach that point, says Fran Gregory, PharmD, vice president of emerging therapies at Cardinal Health, at Asembia 2023.
Will the biosimilars space evolve into a more "generic-like" marketplace or will beiosimilars behave more like reference products?
Yeah, that's a really good question too! Right now, we are seeing biosimilars behave a little bit more like reference products. We're seeing them being treated differently on formularies. We're seeing them come to market with slight variations.
The adalimumab biosimilars are a great example of why they're not exactly like generics. There's variability in biologics in general. So, of course, there's variability in biosimilars. Not only is there innate variability, there's also some slight differences in some of the makeup of these products.
For example, with adalimumab, we have citrate-containing and we have citrate-free, we have high-concentration, we have low-concentration, we have different administrative devices that patients might view as better than others. So, there are a few things that are different about biosimilars and biologics in general that aren't present when we think about simple molecule generics that are all exactly the same.
While we would like biosimilars to look more like generics eventually, there are several things that we kind of have to evolve to get to that place.
I think that the FDA designation for interchangeable biosimilars is, to many people, confusing and somewhat unnecessary. And, we always hear it said that interchangeability of a biosimilar is a regulatory concern, not a clinical concern.
The fact of being approved by the FDA as a biosimilar in every other country in the world means it's an interchangeable biosimilar and it can be substituted for a reference product.
The United States is not there yet, on that piece as well. While I would love to say we're ready to really have a generic like model—I think that would be so much easier for all stakeholders—we're just not quite there in the US yet. There would have to be a lot of changes to policy, a lot of changes to the FDA approval processes and pathways, and we have a long way to go in that regard.