Physician Confidence in Biosimilars Rests on Real-world Data

E. Randolph “Randy” Broun, MD

Providers and health care institutions want more real-world data on how patients respond to various biosimilar products, according to a varied panel of private practice, academic hospital, and group purchasing organization experts in a discussion at the Community Oncology Alliance virtual 2021 Community Oncology Conference in April.

More evidence is the tool for persuading oncology providers to switch to biosimilars, said E. Randolph “Randy” Broun, MD, a blood and marrow transplant specialist with Oncology Hematology Care (OHC), in Cincinnati, Ohio.

“Data are really lacking in this area,” Broun said. “Physicians are going to want data to understand that these truly are biosimilars that are interchangeable, and they’re not shortchanging their patients by doing this, even under pressure from payers.”

At Broun’s practice, biosimilars are a concept that physicians are very familiar with, and they use these agents in many settings. But their confidence in biosimilars can be strained when multiple versions of a single reference product start to appear and they are tasked with making the right choices for their patients.

“Once we have so many Herceptins [trastuzumab], are they all the same? Is it reasonable to simply pull a different one off the shelf for a patient who got something different 3 months ago? That will be a barrier. And you’re only going to solve that with a lot of data that are very convincing that these things are perfectly interchangeable,” Broun said.

According to Sandeep Parsad, PharmD, MBA, BCOP, assistant director of pharmacy at University of Chicago Medicine (UCM) in Illinois, her institution took a very purposeful approach to meet with physicians and nursing staff to talk about the regulatory requirements for approval and demonstrate how biosimilars were comparable with reference products and how they had a high standard for safety and quality.

Sandeep Parsad, PharmD, MBA, BCOP

When it approves a biosimilar, the FDA certifies that it is as safe and effective as the original biologic and that it has been rigorously evaluated. But the FDA does not give it automatic interchangeable status, meaning pharmacists would be free to substitute the biosimilar with a reference product without informing the physician.

“What I’ve heard [from our providers] as well as from other colleagues around the country is physicians prefer to be informed when there is a decision [about] whether or not we should switch from the reference product to the biosimilar,” Parsad said. “But I feel like it went fairly smoothly once there was this very open dialogue.”

It was more of a challenge to develop policies about switching from reference products to biosimilars and in what instances this should occur. Many issues arose, such as whether patients should be asked for consent again before they are prescribed a biosimilar after being on a reference product or if a patient’s condition is stable on a reference product.

Parsad said UCM still wants to see more real-world evidence that shows biosimilars can stand the test of time outside clinical trials performed in limited numbers of patients for FDA approval.

According to Broun, at OHC, providers are now using biosimilars in nearly all situations when it comes to trastuzumab and rituximab and supportive care products, such as growth factors for the control of neutropenia in patients treated with chemotherapy products. But the practice found it more manageable to administer a single brand of biosimilar overall except in instances where payers demand something different.

Panelists said it would be helpful if payers were more lenient about the choice of biosimilars. For example, Parsad noted that the administrative work that goes into payer authorizations could be used on something more beneficial, such as patient education and support.

According to Kathy Oubre, MS, CEO of Pontchartrain Cancer Center in Hammond, Louisiana, who served as panel moderator, these issues resemble growing pains for a relatively new option in medicine that is already proving its value. “The US market is still in its infancy,” she said. “We just need to let it mature. Biosimilars have been, at least for our organization, a great way to help provide some cost savings to the system and the patient.”

Table. Biosimilar Approvals in Oncology