Panel Grapples With the Role of Biosimilars in Oncology

On Friday morning in Chicago, Illinois, The Atlantic hosted a series of panels, moderated by Steve Clemons, on the role biosimilars in cancer care. The event was sponsored by Amgen.

Opening the morning’s proceedings were Gary Lyman, MD, MPH, co-director of the Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, and Chadi Nabhan, MD, MBA, FACP, CMO of Cardinal Health Specialty Solutions.

Lyman said that, while biosimilars are promising for patients, “They don’t do you any good if you can’t get to them,” and cost is a major part of the equation in providing access. But in addition to driving better access to care, Lyman hopes to see biosimilars lower the overall cost to treat cancer in the United States.

For the amount that the United States expends on oncology, he explained, “…our outcomes are no better, and in some case worse,” than in other comparable countries. “One of the goals of biosimilars is to bring that into better alignment.”

Nabhan added that cost will also drive access in other nations, particularly low- and middle-income countries: “It’ doesn’t necessarily just apply here.” However, cost savings need to translate to patients, not simply be absorbed into the healthcare system as a whole.

In Lyman’s view, savings to the patent will not be automatic, but will require an alignment of legislation and policy solutions, including a potential CMS-mandated cap on the price of biosimilars.

In the morning’s second discussion, centered on the US regulatory landscape for biosimilars, Edward Li, PharmD, MPH, BCOP, professor in the College of Pharmacy, University of New England and member of The Center for Biosimilars^® advisory board, said that, in looking at generics in the US market, “we can learn a lot from history.” While biosimilars are distinct from generics, history seems to be repeating itself in terms of stakeholder confidence about these drugs.

The literature from the period before widespread uptake of generics, said Li, is riddled with papers claiming that generics were inferior products. “The tension point is after having years of experience with generics…we’re kind of starting all over again,” said Li.

Christine Simmon, executive director of the Biosimilars Council, agreed, saying that “generics are not made in people’s bathtubs. They’re not made in garages,” and the United States should not have to continue to have the same basic discussions about the quality of FDA-approved biosimilars.

Simmon explained that she is eager for the FDA to issue its promised Biosimilar Innovation Plan and to finalize its guidance on demonstrating interchangeability of a biosimilar with its reference product. She also voiced a hope that the FDA will continue to learn from the European experience and allow EU-licensed products to be used for the characterization process for biosimilars intended for the US market.

However, during the final panel of the morning, which was focused on the patient viewpoint on biosimilars, Andrew Spiegel, JD, executive director of the Global Colon Cancer Association, took issue with the European experience on biosimilars.

Spiegel said that available postmarketing data on EU-approved biosimilars is not adequate to inspire confidence. While it is clear that large numbers of patients are not having notably poor outcomes after treatment with biosimilars, he said, he does not feel that ongoing pharmacovigilance efforts in Europe are sufficient for patients to feel comfortable using these drugs.