Expert Panel Discusses Challenges With Biosimilar Uptake

A panel of health experts discussed the pathway and speed of biosimilar development, as well as the barriers to major uptake of these drugs, during a discussion at the National Policy and Advocacy Summit on Biologics and Biosimilars, held in Washington, DC, on April 17.

Steve Grossman, JD, president of HPS Group, began by dispelling the myth that there can be a comparison drawn between the current generics landscape and the biosimilar approval pathway.

“Leaving aside all the pharmacological differences and the complexity differences between a generic and a biosimilar, it’s just a completely false comparison,” said Grossman. To have an accurate comparison, one would have to look at the generics field in the 1990s, 7 years post-approval, when patients couldn’t simply take any generic in place of an originator product.

“This is one of the handful of times in 60 years that the FDA has a whole new regulatory pathway, and I think they’ve done a good job,” explained Grossman. “I don’t agree with everything they’ve decided, but I think they’ve worked reasonably fast under the circumstances, and I see most of the barriers being things like patient and insurance issues, which [FDA Commissioner] Gottlieb went after. The FDA component is pretty much on schedule, in my opinion.”

While biosimilars have the potential to increase access and save on costs, Allen Meadows, MD, clinical instructor of internal medicine and clinical instructor of allergy at Alabama College of Osteopathic Medicine, and a community-based practitioner at the Alabama Allergy and Asthma Clinic, warned that, with biologics over the years, insurance companies have been making the choice of which brand will get coverage. This practice has led to consequences for some patients, who have had allergic reactions, but the insurance company will force them to use that certain brand anyway.

“I think the key, when we begin to get biosimilars out there, is that there needs to be physician choice,” said Meadows. “A choice that the physician can make in consultation with the patient, so if there’s a 20% risk that this drug won’t work as well or will cause an adverse event, the physician can discuss that with the patient and have a shared decision-making process.”

Grossman agreed, noting that, in approximately 10 years, when the market has matured, physicians will feel more comfortable with substitution. But, said Grossman, we are still in the early stages of the market.

Janet Marchibroda, MBA, director of health innovation at Bipartisan Policy Center, underscored the importance of physician and patient education. She highlighted a survey that found that 40% of biologics prescribers believe that biosimilars are not as safe and effective as their reference biologics, a belief that is a significant hurdle for uptake. Equally concerning, many patients fear biosimilars won’t work as well.

Marchibroda also brought up the legal battles, pointing out that 6 of the 9 approved biosimilars in the United States are delayed from going to market because of ongoing legal disputes with the reference biologic’s sponsor.

According to Meadows, some of the issues with biosimilars are that the price points are not dramatically different from those of the branded drugs. Grossman added that, until we have about 3 biosimilars for a reference product, the US market won’t see the competition needed to drive down prices.

“Once we get competition, which could be a while, and once we get the payment incentives worked out, we still have this other problem that people think that the generic model that’s 60% savings is what we need to get to,” said Grossman. “Why can’t it be 20% of a large number? There’s a lot more to be saved on 20% of a big-time biologic than there is on an 80% discount on a dollar-a-day pill.”

According to Marchibroda, typically those in health policy typically consider the 60% to 90% discount for generics and compare those percentages to 10% to 20% discounts for biosimilars, making it an issue of perception rather than real savings.