Ross Maltz, MD: Understanding Biosimilar Acceptance in Pediatric Gastroenterologists

In an interview with HCPLive,Ross Maltz, MD, associate professor and pediatric gastroenterologist in the Department of Pediatrics at the Ohio State Wexner Medical Center, discussed his recent study “Biosimilars for Pediatric Patients With Inflammatory Bowel Disease: Pediatric Gastroenterology Clinical Practice Survey.” The cross-sectional survey indicated that most pediatric gastroenterologists reported being comfortable prescribing an infliximab biosimilar and were accepting of a one-time switch to the biosimilar for patients in clinical remission.

Ross Maltz, MD

Credit: NationwideChildrens.org

What inspired your team to create a survey to better understand biosimilar acceptance in pediatric gastroenterologists?

The cost of healthcare in the United States has significantly increased and it is well documented that the financial burden of having inflammatory bowel disease can be overwhelming for families. The cost of biologics, medications that are used to treat inflammatory bowel disease, has dramatically increased over the years. This is linked to the increase in healthcare costs, premiums, and deductibles, and a large portion of it is due to pharmaceutical costs. Medications such as infliximab, which has been on the market for over 20 years, and adalimumab, which has been on the market for a while, have seen significant cost increases even though they are essentially the same.

However, with more government interventions and emphasis on biosimilars, which are medications that are very similar to the originator medication, and their studies show very similar results in safety and efficacy, we wanted to understand provider's practice habits and feelings regarding this. Previous studies have shown slow uptake of biosimilars and apprehension of standardization, and many studies have focused on pediatric gastroenterologists. We wanted to get a better understanding of this issue.

Even with adult patients, there is a bit of hesitancy to switch from a biologic to a biosimilar. How do you, as a pediatric gastroenterologist, navigate speaking with parents for a potential switch to a biosimilar?

The study highlights the need for more education among healthcare providers and patients about biosimilars. Another study surveyed pediatric patients and their parents about their understanding of biosimilars and found that most had no familiarity with them. Among parents who had heard of biosimilars, there was a negative association with them, likely due to misinformation or lack of information.

In response, Nationwide Children's Hospital created information sheets about biosimilars to give to families and began proactively reaching out to patients on a medicine that has a biosimilar to educate them about biosimilars in case they had to switch later on. This proactive approach was taken because there are 8 different adalimumab biosimilars hitting the market in 2023, with 1 already on the market. The hospital also developed additional educational resources about biosimilars and is sharing them with other centers around the country to make it easier for providers and patients to access information about biosimilars.

Do you believe that the negative response to biosimilars from parents has to do with a lot to do with a lack of information?

I think there are multiple reasons why healthcare providers and patients may be hesitant to switch to biosimilars. Firstly, healthcare providers may not be up to date on the safety and efficacy of biosimilars, and this lack of knowledge can lead to misinformation and negative associations with biosimilars. Education is extremely important in this regard, and positive communication from healthcare providers can make patients and parents more comfortable with biosimilars.

Secondly, insurance companies mandating the switch without involving patients and providers in the decision-making process can leave a sour taste in their minds. Patients may have been on a medication that has worked well for them for months or even years, and may be hesitant to switch to something different, even if the data shows that the biosimilar is as safe and effective. This hesitancy can be compounded by the fact that patients may have been through multiple different medications before finding the right one.

However, at Nationwide Children's Hospital, we have found that educating our patients makes that a much smoother process.

Why do you think that pediatric gastroenterologists are more comfortable prescribing an infliximab biosimilar in tumor necrosis factor (TNF)-naïve patients?

I think there are 2 different scenarios here. In the first scenario, you have naïve patients who haven't been on the medication before. In this case, the data is extremely clear that the biosimilar works as well as the originator. So, if they are going to start on that new medication, there shouldn't be any issue with using the biosimilar instead of the originator.

In the second scenario, you have a patient who has been on the originator medication for a period of time, and now you are asking them to switch to the biosimilar. Even though the data has shown that there's similar efficacy and safety, I think this situation is different because the patient has been comfortable on that specific medication.

What is the clinical significance of these results?

It emphasizes the need for ongoing education efforts. While there has been progress in educating healthcare providers about biosimilars over time, the survey results suggest that more work is needed. As education improves, we can expect to see increased utilization rates for biosimilars. However, the survey also highlights that some healthcare providers are still not comfortable using biosimilars, whether it's for patients who are starting a new medication or for those who have been on the originator for some time. Therefore, we need to continue educating healthcare providers about the safety and efficacy of biosimilars and the benefits they can bring to patients.

Over the years, myself and many colleagues have gained ample experience with biosimilars. They have the potential to significantly reduce costs for patients and increase access to these medications. Educating not just providers but also patients about biosimilars is crucial to increase their utilization and reap these benefits.

This transcript was edited for clarity.