Removing Need for Switching Studies Could Change Payer Perspectives of Biosimilars

The FDA’s draft guidance to remove the requirement for switching studies to gain the interchangeability designation could change payer perspectives and bring the US more in line with Europe, explained James D. Chambers, PhD, professor, Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center.

This transcript has been lightly edited for clarity.

Transcript

The FDA has published draft guidance to remove the requirement for switching studies for biosimilar interchangeability. What is the current challenge with conducting switching studies and how will getting rid of the requirement benefit patients?

In Europe, we've seen much more success with biosimilars, and I think this is part of it. This is analogous, I think, to generic substitution, which is long-standing policy here in the US that a pharmacy can—as long as it's not explicitly told not to do so by the prescribing physician—it can substitute a generic for the prescribed brand. That's important for these biologics. I work at Tufts Medical Center. Tufts Medical Center would like to stock certain drugs and has an incentive to have certain biosimilars on hand and not others. But then, if the insurance companies determine access, then the patient might require others. It does simplify things, in general, because it provides the providers and hospitals greater flexibility of what they stock and how they use these drugs.

It would change things, I think, from the payer perspective, because with these step therapy protocols and payers requiring the patient to be treated with drug A before drug B or originator before biosimilar or vice versa, that would become less important moving forward, because of this change. It might also change negotiations between product manufacturers and insurance companies, because the large rebates offered are often done to secure preferred status for their product, and if the insurance company can't offer preferred status, then it might impact the magnitude of the rebate offered, which is not what we're looking for.

So, I think, I think it's unclear. I mean, certainly the US has been lagging Europe in terms of biosimilars for a while now. In theory that should speed things up. But given the complexity of coverage policies and so on, I guess we'll have to see.

You see with some of these Humira biosimilars, it’s really expensive to bring a biosimilar to the market. It’s not like a generic. You’re not following a recipe and it’s exactly the same. It is what it is. Biosimilars are a biologic, they’re very costly to produce, and there’s a risk that if insurance companies don’t cover the drug, then the company is going to fail and there’s a real fear, I think, for biosimilar innovators to develop a drug. I think the interchangeability laws would reassure them that their drug might have more of a fighting chance up against the big manufacturers that can negotiate large rebates and a basket of goods, and so on, in their negotiations.