Future Goals of Biosimilar Development Could Support Research Gap, Aiding Pharmacists Interchangeability

In an interview with Pharmacy Times at AMCP Nexus 2023, Kimberly Maxfield, PhD, discussed the role pharmacists can take to reassure patients when switching to a biosimilar, and the future of biosimilar development.

Pharmacy Times

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Clinical effectiveness and safety are among some of the most talked about topics for biosimilars. How can pharmacists assess interchangeability and reassure patients when switching to a biosimilar?

Kimberly Maxfield

This is sort of goes back to some of our educational efforts. From a regulatory perspective, if something is licensed as a biosimilar, it meets the two requirements — it's highly similar, and there's no clinically meaningful difference. There's no reason not to expect that the clinical outcome would be similar. As I just mentioned, the product quality for all of them are the same, there's no difference in the product quality, there's no difference in what is expected. When a pharmacist is talking to a patient, it often comes down to access. There's nothing materially different about it.

Pharmacy Times

What are some potential future considerations for biosimilars and ways to address gaps in research?

Kimberly Maxfield

That's a lot of where the regulatory science pilot program comes from. There's a lot of different ways to push biosimilar development forward. There's actual experience from applications, there's policy development, and there's the regulatory science research gaps —like what scientific information do we need to move it forward, and that's where the right-side program comes in. From there, during the development of that program, it's about a year old at this point, we've defined two program goals. That's to increase the reliance of a demonstration of bio similarity on analytical data. Analytical data typically is more sensitive, it can often be a little bit faster or a little bit less expensive to conduct. It's much more sensitive to detect differences in the context of a comparative paradigm. That's really what we want to fully leverage that piece, when we're looking at an application or development program. Then the second would be developed alternatives or reduce the size of clinical studies or studies using human subjects. Again, a lot of that is in the last decade — we've learned that the clinical data in this comparative context isn't giving us the information that we need to really determine similarity and that they're very expensive and they're very long. If there’s some uncertainty in the analytical data, we would leverage a clinical study. But that isn't necessarily or shouldn't necessarily be the default.