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Clinicians' Understanding of Manufacturing Changes


Gillian Woollett, MA, DPhil: For clinicians, do you think this whole idea that the originators vary but biosimilars vary too, and they’re all within the same range as overseen by the same people at the FDA—is that a useful message?

Kashyap Patel, MD: It probably would be a very useful message because there are a lot of physicians who are on the fence right now, not understanding the class as a whole. So something coming out from the FDA highlighting that the originator has undergone multiple modifications without compromising the quality, efficacy, or safety—it would reassure the physicians who are prescribing that yes, I’m not going to compromise the quality of care because I’m choosing something that’s likely less expensive but I’m going to sustain and maintain the quality of care.

It would be extremely helpful information coming out from the FDA. Because for me, I don’t have personal expertise in judging all these aspects. But I trust the FDA as a very reliable source of information that would help me make very important treatment decisions.

Gillian Woollett, MA, DPhil: And this is a good message, I think, that the FDA is doing its job. They are overseeing all biologics to the same standard, consistently. Therefore, physicians, patients, providers can have equal confidence.

Carlos Sattler, MD: Just to give an idea of the scope of biologics that have been available since recombinant technology actually became available—we’re talking about the 1980s—there’s a recent publication—actually, this year—that identified approximately 260 biologics that have been approved since. And you can expect that virtually all of them, or most of them except maybe the most recent ones, have undergone some manufacturing change. And in just 3 cases were there any issues between the pre— and post–manufacturing change product—1 of them having some significant safety issues… and some of these happened, like, decades ago, right?

Kashyap Patel, MD: Yes.

Carlos Sattler, MD: And the scrutiny and the process and the released specification for products now are even tighter, but that should speak to how controlled manufacturing changes are and how the comparability exercise is so very well refined. And understanding, again—like you mentioned, Gillian—that the scientific concept behind comparability and biosimilarity is the same would, I think, go a long way in accepting biosimilars as high-quality products.

Gillian Woollett, MA, DPhil: And certainly one thing that I’ve always noted is, given the extent of the data by about the time a biosimilar is approved, on both the originator and the biosimilar, we do have to bear in mind that the product that we always know the least about at the point of initial approval is the truly innovative product, and we all want those approved. This is a risk—benefit exercise. We’re trusting the FDA to it, and they’re doing it based on some very, very well-founded science and principles. So I think that context is important because we want the new, cool products too.

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