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The FDA's Approach to Biosimilar Education


Carlos Sattler, MD: Let me address the comment that Kashyap made, which is that the FDA approves a product, and then your opinion is that the responsibility for education should be more at the provider level, or from providers or personal societies.

Again, as I mentioned, I think every stakeholder should be involved in education, and it can take many forms. But what we’ve observed from the FDA in the last year or 2 is a different approach.

For example, when they published their biosimilars action plan in July of this year, that is something that I thought was somewhat unexpected from the way the FDA normally operates. I think it has a lot to do with their perspective—a lot to do with the Commissioner, Scott Gottlieb, who really believes that biosimilars are part of the solution to increasing health care costs, so they’re taking action. We’ll see how far it goes, but I have expectations that they will actually adopt a different approach to biosimilar education and their interest in adoption in a healthy biosimilar market rather than the FDA did before.

Gillian Woollett, MA, DPhil: And then others can get that information out there.

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