Julie M. Reed, the new executive director of the Biosimilars Forum, offers her opinion on how interchangeability will impact US biosimilar uptake now that the FDA has given the designation to 2 biosimilars.
Julie M. Reed, the new executive director of the Biosimilars Forum, offers her opinion on how interchangeability will impact US biosimilar uptake now that the FDA has given the designation to 2 biosimilars, Semglee (insulin glargine) and Cyltezo (adalimumab).
Now that we have 2 interchangeable biosimilars, how do you think the interchangeability designation will play a role in adoption?
Reed: I think interchangeability creates confusion. And one of the key things that we want to be sure about at the [Biosimilars] Forum is that confusion about interchangeability does not also create misinformation about interchangeability or biosimilars overall. So, with the congratulations to both the companies that have interchangeable biosimilars approved and their members.
Really what interchangeability is [focuses on] substitution at the pharmacy level. The biosimilars, whether they're interchangeable or not, have the same standards of quality, safety, and efficacy. There's additional work [regarding] interchangeability for pharmacy substitution. I believe that will help uptake at the pharmacy level, retail pharmacy level. But that does not limit the ability for payers or anyone else to put any and all biosimilars on the formularies. And that's where we're concerned that confusion will occur.
Until these 2 biosimilars were approved for interchangeability, payers and [pharmacy benefit managers] still have access and still can we encourage them to provide parody access to formularies for all biosimilars, interchangeable or not. They're doing that now. They can have more than 1 biosimilar on their formulary, they're not interchangeable, but they can still put those all the biosimilars, all the Humira [adalimumab] biosimilars, on a formulary. Patients like the choice. Physicians like the choice. They'll have greater competition by having all biosimilars on a formulary. If you have an exclusive contract with just 1 biosimilar and that parity, you're not getting the best out of your competition and it's the competition that's going to lower the cost.
So, with interchangeability, we're working to educate what it is and what it is not. And we're really solidifying for patients and physicians that we believe in choice and we believe that all biosimilars have the same safety, quality, and efficacy standards.