Dr Joe V. Selby on Biosimilar Research

The Patient-Centered Outcomes Research Institute (PCORI) will approach biosimilar research the way it does research on anything else, but there is the added element of finding the right timing, said Joe V. Selby, MD, MPH, executive director of PCORI.

Transcript (slightly modified)

How does PCORI plan to address biosimilar research now that the FDA has approved the first one in the United States?

We'll approach research on biosimilars like we approach on research on everything else. We are beginning to hear from stakeholders that we should be interested in biosimilars. We're prepared to beleive they might be right, but we're going to want to get multiple stakeholders together and then prioritize the question. And sometimes the most challenging work, from anyone's perspective and particularly from the perspective of multiple stakeholders at the same time: what is the right question? What's the question that will change practice? What's the question that the answer will endure?

It's a lot of fun. People enjoy doing it. It makes a lot of sense that you would try to get patients, payers, manufacturers, and clinicians in the same room, to discuss these topics. But I will say, and all of them will say too, that's hard work—identifying the exact right questions. But in biosimilars, it will go through the process of being reviewed, we will prepare a topic brief on the question, we'll go to the advisory panels.

I think with biosimilars one of the questions is: when do we start? We like to be there early. But you could get there too early in this country. So we need to get the questions right. See if multiple stakeholders agree that this is high-priority research for PCORI and determine the best time to start.