Panelists Explore What Exactly Is Holding Up US Adoption of Biosimilars

Big changes are needed to overcome barriers to US biosimilar adoption, including those involving payers intervening in formulary decisions, confusion regarding interchangeability, and issues with disseminating biosimilar education, according to panelists in a recent webinar.

The webinar, titled “What’s the Hold-Up? Overcoming Barriers to the Use of Biosimilars,” was presented by The Center for Biosimilars^® and sponsored by Samsung Bioepis. During the discussion, moderated by Tony Hagen, senior editor at The Center for Biosimilars^®, the panelists examined some of the major barriers to biosimilar adoption in the United States and offered some solutions to help the industry break through.

Limiting Provider Choice and Patient Savings

Although there are cases where providers choose not to prescribe biosimilars, physicians often have a limited ability to choose a biosimilar therapy for their patients because of payer involvement in formulary placements, according to Madelaine Feldman, MD, FACR, president of the Coalition of State Rheumatology Organizations.

Providers may be forced to fight harder for their patients to receive the biologic that works best for them and prevent them from experiencing the nocebo effect when switching products, which is a large concern in chronic disease spaces. This is because patients may have had to try several products before finding one that works for them, such as those with rheumatologic conditions, Feldman explained.

In addition, sometimes the savings stemming from biosimilar utilization don’t have an impact on patient costs, further contributing to challenges with financial toxicity, particularly in the oncology space, according to Sameer Awsare, MD, FACP, associate executive director at Permanente Medical Group.

“Some of our oncology patients are sometimes on 3 different biologics, and that is so expensive. Often, they're thinking of selling their house or thinking, ‘Should I even get treatment because I may leave nothing for my kids?' And solving that issue for our patients is really what I wish for,” he expressed.

The Confusing World of Interchangeability and Education

Interchangeability designations are another topic of concern for biosimilar adoption because confusion about what the label means can trick providers and patients into believing that interchangeable biosimilars are superior to other biosimilars for the same reference product, which is a false conclusion, the panelists said.

“We still hear periodically from different provider types or even pharmacies across the country that when they're valuing biosimilars, they might say, ‘Oh, we're going to wait until they're interchangeable.’ And we know for many of these products, they might be waiting a lifetime, unless the FDA changes the path to achieve that designation. So, there's still quite a bit of knowledge gaps that need to be filled,” explained Sonia Oskouei, PharmD, vice president of biosimilars at Cardinal Health and an advisory board member for The Center for Biosimilars^®.

In addition to miscommunication on interchangeability, calls to action for more education material directed at patients and providers have been growing for some time. However, Ryan Haumschild, PharmD, director of pharmacy at Emory Healthcare and Winship Cancer Institute and an advisory board member for The Center for Biosimilars^®, pointed out that there needs to be better dissemination of existing educational material.

“There is potential to see some more medical education around biosimilars even at different [health care conferences]…where you don't see a lot of information around biosimilars…. And I feel like the FDA has created resources but haven't really created the construct to engage with those frontline providers, especially in the communities that might have competing priorities,” Haumschild noted.

Will the US Ever Catch Up to the EU?

In the European Union, patients see lower prices for the same drugs marketed in the United States, and the region has had a decade head start on biosimilars compared with the United States. Biosimilars that aren’t allowed to enter the market in the United States, such as those referencing Enbrel (etanercept) and Humira (adalimumab), because of patent disputes and settlement have been on the market in Europe for years.

Additionally, many European countries have tender systems, where companies use drug prices to compete with each other in hopes of being chosen for the nation’s list of covered medications for a set amount of time. Feldman proposed that systems in Europe encourage lower prices, whereas US systems encourage price increases.

“When you look at European prices vs US prices, in Europe, lower pricing, not lower cost, actually gets you the bid. The government doesn't act as a middleman where you have to bribe them. You just offer it at a lower percentage. Whereas, in the US it's a perverse incentive to raise prices…. So, the approval process is great to talk about, and I think we need to applaud the FDA for what they've done. But to get those less expensive medications into the hands of the patient is going to require a little bit of an upheaval in the drug supply chain,” explained Feldman.