Gary Lyman, MD, MPH: Biosimilars and Policy

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.