Russell D Cohen, MD: Understanding the Role of Biosimilars in Healthcare

Russell D Cohen, MD

Credit: University of Chicago Medicine

In an interview with HCPLive, Russell D Cohen, MD, a gastroenterologist and professor at the University of Chicago Medicine, discusses the value of the introduction and expansion of approved biosimilars in the United States and eases potential concerns clinicians may have when debating to prescribe a biosimilar to their patients.

Biosimilars are often touted as a way to reduce healthcare costs. Can you elaborate on how biosimilars contribute to cost savings for patients and the healthcare system as a whole?

While coverage and availability will ultimately depend on a patient’s health insurance plan, biosimilars allow for more treatment options and potentially at a substantial discount to the reference biologic. The average sales price for biosimilars is on average 50% less than the reference brand biologic price.¹

This means biosimilars may reduce costs to the health care system overall and to patients if their out-of-pocket payment for a medicine is based on a percentage of its list price.¹

In my experience, this can be particularly important in cases where a specific biologic is not available or affordable for patients based on their health insurance plan or status. For patients challenged by affordability, lower-priced biosimilars can expand access to biologic treatments – and greater access can lead to improved outcomes and better disease management.²

Biosimilars can also provide value across the health care system. According to experts, as biosimilars become available to the public, increased competition from more products can potentially decrease costs to the health care system. These cost savings may help increase access to biologics and may be reinvested in other areas of the health care system.^3,4

Some patients and healthcare providers still have concerns about the safety and effectiveness of biosimilars compared to their reference biologics. What would you say to address these concerns?

First, it’s important to explain that the US Food and Drug Administration (FDA) carefully reviews studies of biosimilars to ensure that there are no clinically meaningful differences in safety and effectiveness compared to the original biologic.⁵ Biosimilars must go through a rigorous development and testing process, and the FDA monitors safety and effectiveness after approval.^6,7,8

Both a biosimilar and the reference biologic are expected to have similar treatment benefits and potential side effects and are generally given at the same strength and dosage. This means that generally patients should not experience any change in their treatment plan when transitioning to a biosimilar from a reference biologic.⁵

From a medical perspective, what are the key factors that patients should consider when discussing biosimilars with their physicians?

As with any decision about starting or transitioning a medicine, a patient should talk with their doctor about what is best for them. Patients should ask about potential side effects or changes in their treatment plan. They should also voice any general concerns they might have about switching to a biosimilar.

In my experience, I’m also aware of the impact that costs can have on medication adherence. Many specialty biologics can carry a high out-of-pocket cost for patients, and I think health care providers (HCPs) should try to be aware of the potential financial burden on patients. As lower-priced biosimilars become available, cost can now be part of the discussion of care with patients. Patients may be interested to know about ways to continue their treatment with a biosimilar while also potentially lowering their medication costs, depending on their insurance plan.

With my patients, I explain that the potential side effects associated with biosimilars are similar to those associated with the reference biologic, so, generally, patients should not experience any change in dosage or treatment plan.⁵ I also assure patients that the FDA carefully reviews studies of biosimilars to ensure there are no clinically meaningful differences in safety or effectiveness compared to the original biologic.^5,7

Can you provide insights into the ongoing research and development of biosimilars and how they might continue to evolve in the healthcare landscape?

I am encouraged to see additional treatment options for patients become available as more biosimilars are approved by the FDA, and I think it’s important to help increase understanding among HCPs and patients of the scientific rigor behind biosimilars and the benefit of biosimilars to patients and the health care system.

In your opinion, what role will biosimilars play in the future of healthcare, and how might they impact patient care and access to treatment?

Many experts would agree that there is significant potential for competition from biosimilars to improve access and drive down costs – something that generics achieved for the US health care system in the 20th century.^3,9 As a doctor, I think the potential opportunity for biosimilar adoption to expand choice, access, and affordability of biologic medicines is important.³

Is there anything else you’d like our audience to know?

I’ll use this opportunity to underscore one last time that biosimilars represent an opportunity to expand access and potentially help to reduce the financial burden of high-cost biologics – and there are no clinically meaningful differences between a biosimilar and its reference biologic.^3,5

For more information, the US FDA website has a variety of resources about biosimilars for HCPs and patients.

References

1. ^{Association for Accessible Medicines. (September 2022). The US Generic & Biosimilar Medicines Savings Report. Accessed September 26, 2023. https://accessiblemeds.org/sites/default/files/2022-09/AAM-2022-Generic-Biosimilar-Medicines-Savings-Report.pdf}
2. ^{IQVIA Institute for Human Data Science. (2020). The Impact of Biosimilar Competition in Europe. IQVIA.}
3. ^{Aitken M, Kleinrock M, Pritchett J. Biosimilars in the United States 2023-2027: competition, savings, and sustainability. IQVIA Institute for Human Data Science. January 31, 2023. Accessed September 26, 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2023-2027}
4. ^{Aitken M, Mugele D, Newton M, Rodríguez I, Vázquez M. Spotlight on Biosimilars. IQVIA Institute for Human Data Science. June 2021. Accessed September 26, 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports/spotlight-on-biosimilars}
5. ^{Biosimilar basics for patients. US Food and Drug Administration. March 21, 2023. Accessed September 26, 2023. https://www.fda.gov/drugs/biosimilars/biosimilar-basics-patients}
6. ^{Biosimilars Review and Approval. US Food and Drug Administration. December 13, 2022. Accessed September 26, 2023. https://www.fda.gov/drugs/biosimilars/review-and-approval}
7. ^{Biosimilar Development Process. US Food and Drug Administration. Accessed September 26, 2023. https://www.fda.gov/files/drugs/published/Biosimilar-Development-Process.pdf}
8. ^{Biosimilar Regulatory Review and Approval. US Food and Drug Administration. Accessed September 26, 2023. https://www.fda.gov/media/151061/download}
9. ^{Stark A. Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA's Biosimilars Action Plan. US Food and Drug Administration.July 18, 2018. Accessed September 26, 2023. https://www.fda.gov/news-events/press-announcements/remarks-fda-commissioner-scott-gottlieb-md-prepared-delivery-brookings-institution-release-fdas}