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.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
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?
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.
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.
PBM Evolution Toward Value-Based Care Shifts to Transparent Pharmacy Pricing
March 30th 2025Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health, predict pharmacy benefit managers (PBMs) will evolve toward value-based care, mirroring the broader shift toward open-cost structures.