Adam Colborn, JD, director of government relations at the Academy of Managed Care Pharmacy (AMCP), also explains what health systems can do to improve patient access to biosimilars.
"The absence of interchangeability in the biosimilar market really is a pretty big obstacle for patients and pharmacists who are trying to dispense them," said Adam Colborn, JD, director of government relations at the Academy of Managed Care Pharmacy (AMCP).
How does the regulatory landscape of biosimilars vary between states?
Biosimilar regulation doesn't really vary too much between states. I think the clear overarching trend is a deference to federal authority and FDA assignment of interchangeability.
All states, except Hawaii, specifically incorporate federal statutory law into their biosimilar substitution and interchangeability laws. Often they include references to the Orange Book or the Purple Book, and so there's not a ton of variety between states. They don't necessarily all use the Orange Book or the Purple Book, or sometimes they cite to slightly different parts of the US Code, but for the most part they're pretty aligned on that. Hawaii, like I said, is the exception. They maintain their own state level list of interchangeable drugs that governs substitution in the state.
I think a uniform nationwide approach to biosimilars is preferable to a patchwork of state-level regulations, but I think the federal obstacles to interchangeability and biosimilar substitution leave a lot of room for improvement.
How can interchangeability pose as a barrier in the biosimilars market?
The absence of interchangeability in the biosimilar market really is a pretty big obstacle for patients and pharmacists who are trying to dispense them. There's a much higher regulatory benchmark for a biosimilar to receive an interchangeable designation than a small molecule drug.
Biosimilars have to, one, demonstrate that they are highly similar to the originator product, but they also have to demonstrate certain levels of potency, of purity, and then safety, as well. When we compare that to small molecule drugs, small molecule drugs only have to demonstrate that they are bioequivalent to the brand name. They have to have the same potency of the active ingredient over the same amount of time, which is much easier to do.
Until we get that interchangeable designation, we won't see pharmacists who are able to substitute biosimilars at the pharmacy counter for brand name prescriptions for the originator product. That could potentially result in patients having to pay higher costs than they would if they could access the biosimilar product. Taking a step back to the plan and benefit level, it also limits plans' ability to use traditional utilization management techniques, such as step edits, because if they're not interchangeable, you can't start with the biosimilar product in the first tier and then step up to the brand name. So, those are some pretty big obstacles to increased utilization of biosimilars due to the lack of a convenient interchangeability process.
What role do health systems play in the fight for improved biosimilar legislation and policies?
I think what would be most useful is for direct patient care providers, like doctors or nurses, to leverage their expertise with policy makers and say that this is something that will benefit their patients.
Pharmacy groups have been engaged in this for a long time, but we're really not seeing the same level [with direct care providers], and I think that mostly comes down to a lack of familiarity with the idea of biosimilars among a lot of direct care providers.
I think hospital groups and hospitals can get involved in this as well—more voices are always helpful. But the provider perspective is really influential and really powerful with policy makers. So I think that would be what's most helpful for improving patient access to biosimilars.