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Amanda Forys on How Biosimilars Are Being Approached on the State Level

States are addressing biosimilars in different ways and putting different regulations in place as biosimilars become more prevalent in the market, explained Amanda Forys, MSPH, director of Xcenda’s Reimbursement Policy Insights consulting team.


States are addressing biosimilars in different ways and putting different regulations in place as biosimilars become more prevalent in the market, explained Amanda Forys, MSPH, director of Xcenda’s Reimbursement Policy Insights consulting team.

Transcript (slightly modified)

States are approaching biosimilars in different ways; what are some of the most common state legislative actions that we’re seeing?

Currently, a biosimilar product cannot be substituted at the pharmacy if it’s just an approved biosimilar. Now, if a manufacturer pursues interchangeability, you can then take the product and a prescriber could write a prescription for the originator product. But, if it’s got interchangeability on the biosimilar side, the pharmacist could, in theory, switch the patient over and it not be a huge issue because you received that approval from the FDA to do so. What states are looking for though is some more clarification around that, because even the FDA is giving some guidance around what’s interchangeable, but they are not really giving complete clear guidance. They’ve even said that application of what we want would be a little bit different for every product, and we recognize that this is a little bit of a fluid process. That is something that has yet to be completely defined, so states are kind of doing their own thing.

What they’re mostly doing is setting regulation around if there is a pharmacist that takes a patient and puts them on an interchangeable biosimilar, they are required to notify the prescriber within 5 days that the switch occurred. That’s probably the biggest and most consistent thing we are seeing across states. A couple states have just said that, yes, we will allow for this substitution if it is interchangeable. South Carolina has done something interesting, where they just took their list that originally had things that could be substituted with a generic and have now said that biologics could have a substitution for something that is interchangeable. So just really defining the parameters of what could happen at the point of sale for the patient when the pharmacist is filling the script, but they haven’t really changed or gone beyond anything, in theory, that could affect the market otherwise.

 
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