Adam Colborn Reviews Biosimilar Interchangeability Requirements, Advocates for Pharmacist Resources

Adam Colborn, JD, director of government relations for the Academy of Managed Care Pharmacy, explores the efforts policymakers can take towards interchangeability and ultimately remove switching study requirements altogether. Colborn delves into the different regulations the US and Europe have when it comes to biosimilars. He stresses the importance in equipping pharmacists with proper educational resources and training that ensures confidence among biosimilar interchangeability.

Colborn presented his session titled, "Breaking Boundaries with Interchangeable Biosimilars: The Sequel", at the Academy of Managed Care Pharmacy (AMCP) 2024 annual meeting, where he discussed the regulatory landscape of interchangeable biosimilars, their outcome on formulary management and benefit design, as well as emerging regulatory trends. Operating as the director of government relations, Colborn has led advocacy and state policy work through his support of AMCP's direct federal Congressional lobbying. His professional experience in public policy and professional advocacy has allowed Colborn to work on both state and federal levels.

Transcript:

What should policymakers keep in mind as they work to clarify interchangeability or make efforts to remove switching study requirements or the designation altogether?

I think the most important thing for regulators and policymakers to keep in mind as they're looking at potentially eliminating switching studies from the requirement to designate a biosimilar as interchangeable is how that's worked out in Europe.

There's some data that's come out recently from Europe that switching studies do not offer any additional information beyond the typical interchangeable, interchangeability application process. So that extra step really seems to be an unnecessary hurdle to the process. I think I would look at what other countries, mainly Europe, have done in that space before.

Pharmacists play a crucial role in dispensing interchangeable biosimilars. How can we ensure they are equipped with the necessary knowledge and training to confidently counsel patients on biosimilar interchangeability?

I think pharmacists, like other types of providers, need additional education on the biosimilar issue. Right now, the legal framework for biosimilar interchangeability is very complicated. For example, a biosimilar that is interchangeable with the reference product is not automatically interchangeable with another biosimilar. That's been a big obstacle for uptake of biosimilars because when we look at generic switching, it's much easier for someone to say well, I have X generic in stock so I'll dispense that instead of Y generic.

With biosimilars, they don't have that flexibility. In addition to the education to make pharmacists more comfortable with biosimilar interchangeability and switching, I think policymakers need to step in and take a role in clarifying when a biosimilar can be switched for another biosimilar that has been designated as interchangeable with the reference product.