Gary Lyman, MD, MPH, of the Fred Hutchinson Cancer Research Center and Seattle Cancer Care Alliance, discusses policy challenges with biosimilars.
Transcript
At the policy level, among professional organizations like [the National Comprehensive Cancer Network, NCCN], again, I think there’s this hesitancy. This need to be educated. There, I think the biggest issue is they want to see the data. They want to see the evidence, and since these drugs are being approved by the FDA, sometimes that evidence is put in the public domain; it’s put on the web. If there's an Oncology Drug Advisory Committee meeting, all that's in transparent and available.
But the more recent biosimilars have been approved without that public disclosure. There, it's really critical that industry, that companies publish their data, their preclinical data and their clinical data, in the peer-reviewed literature.
We had one example recently, and that complicated our NCCN guideline update for the hemopoietic growth factors, where we neither had the public display of the evidence that the FDA reviewed nor any peer-reviewed publications. So as a guideline panel, we could not really recommend the use of that agent.
Eventually, the company forwarded that information to us directly, but my point is, FDA approval is just the first step, and equally important is that the evidence that the FDA reviewed for approval these agents has to be made available to the medical community, to the professional community, and to professional organizations like NCCN if they're going to be expected to endorse and recommend the use of these agents.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
BioRationality: Commemorating the 15th Anniversary of the BPCIA
April 8th 2025Affirming that analytical characterization is often sufficient for biosimilar approval, minimizing unnecessary clinical testing, and enhancing FDA-led education to counter stakeholder misconceptions are key recommendations put forth in this opinion piece by Sarfaraz K. Niazi, PhD.