When it comes to biosimilar adoption, it seems like the healthcare industry remains in a bit of a holding pattern. While the FDA has now approved 25 biosimilar or follow-on biologic products, less than half are actually available on the U.S. drug market.
Cate Lockhart, MS, PharmD, PhD, executive director of the Biologics and Biosimilars Collective Intelligence Consortium, an organization that addresses important questions about the use, impact, safety, and clinical effectiveness of biologics and biosimilars on human health, says there have been many barriers to entry that have yet to be successfully overcome.
“Some of it stems from the difference in how our healthcare system is structured in the United States as compared to Europe, where biosimilars are doing quite well,” she explains. “Everyone has been a bit surprised how hard it’s been to grow the biosimilar market. But I think of it as being very similar to generics 20 years ago.”
Over the past decade, the use of generic drugs has saved the U.S. healthcare system over $1 trillion. But Lockhart says, it took some time to get there.
“We see some of the same barriers now in biosimilars as we saw back then,” she says. “Lots of patent litigation, of course. The FDA was a little sluggish at first in granting approvals, though that has now picked up in pace. But approval doesn’t always equate with market access. So, one of the biggest barriers is the kind of contracting that is going on that keeps biosimilars a bit stuck. And there remains a lot of uncertainty with prescribers and patients, too. These are all obstacles that need to be addressed so the uptake we expect will actually happen.”
Lockhart joined Molly Leber, PharmD, BCPS, FASHP, associate director of Drug Use Policy and Formulation Management at Yale New Haven Health, and Gillian Woollett, MA, DPhil, senior vice president at Avalere, at the Academy of Managed Care Pharmacy (AMCP) Nexus event, to be held October 29-November 1, 2019, in National Harbor, Maryland to discuss the current—and future—landscape of biosimilar products in their session, “Biosimilars in the United States: Barriers, Solutions, Real-World Evidence, and the Experience of One Health System.” The session was held on October 31, 2019 from 3:00 p.m. to 4:30 p.m.
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With so many stakeholders with a dog in this particular fight, Lockhart says it can be difficult to come up with solutions to help facilitate more biosimilar adoption. Most organizations are too focused on the short-term bottom line.
“When people are thinking about how to make their financial obligations for this quarter, they want to use the least expensive product,” she says. “So, when companies are coming in and providing rebates and contracts for the traditional drugs, it really can shift the market dynamics.”
But Lockhart says specialty pharmacy and managed care organizations would benefit from taking a long view of the situation. Some payers and healthcare organizations are fully adopting biosimilars—and as their successes are observed, she believes more organizations will jump on the bandwagon. And as the biosimilar market expands, it will pay for organizations to have access to the right information. She said it is imperative that stakeholders get their hands-on, real-world evidence and data to help guide their decision-making.
“We have a ton of data about these products, in various stages,” she says. “It’s disjointed and hard to leverage. But the FDA Sentinel Initiative has brought some data harmonization—and that can be used for analysis. Which allows us to answer some of the big questions about biosimilar use as well as to address some of the uncertainties that stakeholders may have, whether they are payers, patients, or the physicians themselves, about what will happen when these products get out into the wild—in a regular setting, not just a clinical trial settings.”
Kayt Sukel is a science and health writer based outside Houston.