Shubha Bhat, PharmD: The Future of Biosimilar Use in IBD


There is no clinically meaningful differences in safety and efficacy between biologics and biosimilars.

Investigators are hoping to build on the success of biologics in recent years in treating inflammatory bowel disease (IBD) to find similar success in the future with a class of medications called biosimilars.

This class of drug is very similar to the biologics but are not considered to be generic despite no clinically meaningful differences in safety, purity, and potency.

Recently during the Crohn’s and Colitis Congress 2022, Shubha Bhat, PharmD, Cleveland Clinic, talked about the potential of this class of drugs.

HCPLive: Can you summarize your presentation on biosimilars from the Crohn’s and Colitis Congress?

Bhat: The panel and I discussed definitions and we also talked about existing evidence about biosimilar use in patients with IBD. And we also addressed areas such as the placebo effect and biosimilar misconceptions.

Some key take-home points from the presentation of phase one pilot trials of biologic products have shown to be similar to FDA-approved biologic products and no clinically meaningful differences from the safety and efficacy of existing products for IBD.

Finally, patient and provider education is critical in optimizing biosimilar uptake.

HCPLive: What are the major concerns for patients treated with this class of drugs?

Bhat: The major concerns patients have about biosimilars is why are they being asked to switch from their existing treatments to this class of biosimilars. And what we know about inflammatory bowel disease is that it can be a very challenging disease for patients because it is a chronic disease and it does have a relapsing and remitting course.

So when a patient achieves remission on a medication, they feel concerned they are being asked to change their treatment when they are doing clinically well. And although we know that biosimilars are highly similar to existing FDA approved biologic agents and has not led to any worsening outcomes. Ultimately patients do not want to make any changes if the treatments are working for them.

Another challenge that kind of goes hand-in-hand is that biosimilars cannot be considered generic because the molecular design of these medications are very complex.

HCPLive: Is there a difference in outcomes using biosimilars between patients with Crohn’s disease and patients with ulcerative colitis?

Bhat: Not at all. We actually have several studies that have evaluated biosimilar use in both Crohn’s and ulcerative colitis. These studies have found similar outcomes. Ultimately both groups of patients should be comfortable with biosimilar use.

HCPLive: There has been a lot of development and progress made in recent years for biologics as a treatment for IBD. Do you see a similar trajectory in the future for biosimilars?

Bhat: That’s what we’re hoping. There’s a lot happening with the biosimilar landscape. I can tell you that insurance companies are starting to adopt biosimilars. So definitely on the use of biosimilars we are going to anticipate growth as well.

There are some situations and some questions we might still have that need to be better answered on how many biosimilar treatments can a patient undergo without compromising safety? I know this area is being evaluated.

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