Optimal Management of Biologics in Crohn’s Disease - Episode 13

Role of Biosimilars for the Management of Crohn’s Disease

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Bincy P. Abraham, MD, MS, AGAF, FACG, and Jennifer Seminerio, MD, comment on emerging data for interchangeability of biosimilars and biologics when treating Crohn’s disease.

David P. Hudesman, MD: We just had a great discussion on our current therapeutic options. But we have 3 biosimilars now in the US, for infliximab and coming next year, we're going to have multiple. I don't even want to know how many for adalimumab. Dr Abraham, if you could comment on the biosimilars, is this a concern, is this something that's an easy switch for you?

Bincy P. Abraham, MD, MS, AGAF, FACG: The data for biosimilars is out there now. At least right now, we can be comfortable with the evidence that biosimilars, the switching that's going to take place soon, especially with the adalimumab category, that it will be safe, it will be efficacious. We don't necessarily have to worry that when the patient switches they're going to have lower efficacy or end up having more safety concerns. The data is there that it is safe to do so. The emerging information that we're getting for these biosimilars is that initially, the FDA did not account or accept for interchangeability. But in real life practice, we're having patients who switch jobs, they end up being on the bio-originary drug, then switching to the biosimilar and then they switch to another job or move away, and they must go back to the originator or back and forth with multiple biosimilars. And that was initially concerning to me. But now the data is emerging that interchangeability might be OK. So, if the FDA actually allows for that for all of our biosimilars moving forward, now that we have the data, I feel very comfortable discussing them and choosing it, of course, for the patient. Patient's concerns are that, Oh it's biosimilar. Is it OK for me to switch? I want to make sure that I stay on the originator. But what could happen often is that if we end up trying to appeal to the patient because they want to stay on the originator and try to appeal to the insurance to keep them on the drug. Now, with the data, the insurance companies are also saying, no we're not going to do that. That ends up delaying our patients care of being able to get the medication on time. I'm highly encouraging my patients who demand that they stay on the originator biologic that we absolutely should not do that. It's going to put your health in danger. And with the anti-TNFs, we know that if you delay therapy for too long, they're going to be at increased risk of developing anti-drug antibodies. We must, as providers, to be able to educate our patients that biosimilars are OK. They are fine to switch. There's no increased risk of safety concerns or lower efficacy. And avoid that nocebo effect where the patient is concerned and will end up having an adverse effect of the medication because they are so concerned about it. It's kind of like the anti-part of the placebo effect I've encouraged my other healthcare providers, my office staff, my nurses, my infusion nurses, when a patient asks about it, that you don't discuss it. Oh, my gosh you're going to be switch to a biosimilar? Oh my gosh that's going to be scary. We don't have that discussion at all. We say, Oh that's fine. We have data. It’s the same as your originary biologic. Shouldn't be a problem. Let's go ahead and make the switch and we'll talk about how to get that ready for you.

David P. Hudesman, MD: Yes.

Jennifer Seminerio, MD: This is an area where we have such power as providers and how we move forward with this. From everything you said, I think from the standpoint of the way we present the drugs moving forward is not using brand names and really focusing on the generic name of it that when there are these switches, they're- you don't have to have that discussion. When you're dealing with interchangeability, it’s all about trying to minimize the anxiety that goes into that when they've had an effect. And there's so much with that. But beyond everything that we can do, we have a power in our education to the community on this. If we, as IBD-ologists, stand and say, interchangeability is OK. Do not delay treatment. I think then the community providers are going to feel more comfortable with it, they're going to fight it less, and ultimately, it's going to be beneficial for our patients down the line. I think it's all about being calm with this. The data is out there, and this is something that we're now going to see a lot in the coming year.

David P. Hudesman, MD: It's a great point and education is key and I think when the ifliximab biosimilars first came to market in our practice, we were struggling, the insurances, the- our back end team was trying to get authorization, things were getting switched in how to communicate. And now, I think what's extremely important is we have a system in place is when this coming up. We all know it's not a big deal but how do you communicate that to the patient that they feel the same way ahead of when they get a letter from the insurance, or they hear from somebody else? And that's key and once we figure that out it'll be just fine with adalimumab as well. It's the messaging.

Transcript Edited for Clarity