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Sheila Frame: Switching to a Biosimilar


Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, discusses patient concerns about switching to a biosimilar.


So I think the whole issue of switching stable patients certainly continues to be the highlight of many debates, both for physicians as well as for associations and patient groups.

And so I do think it's something that certainly at Sandoz we take very seriously. I do think though, you know, if you think about a patient who's been well controlled on an originator product, they've already been subjected to biosimilar switching. Every batch that they've had over whatever period of time has been a biosimilar.

And so I think that they're—I totally support and understand what the concern would be. Don't mess with my—especially if you're subjected to pain. Nobody wants to go back to that world when you talk to some of these patients and the patient associations. You just wouldn't want to put anybody through that.

At the same time, given the requirements under the [Biologics Price Competition and Innovation Act, BPCIA], I think also just what we actually do in order to prove the safety and efficacy, I really think it's worth a try. I really do. I think I would say to a patient, you know, be open, give it a shot, and then the value that's created in the system to free up the capacity to fund those new innovations that are coming I think is probably worth taking the chance, in the appropriate context.

I mean, I'm not a physician. So I'm not going to give medical advice, but I definitely think that given the publications and the experience, we've had years of pretty massive switches in many of the European countries, and we haven't seen any issues emerge over time. So, while, again, I understand the concern, I just think that the safety and efficacy that we've been able to prove and demonstrate with the kind of exposure that we've had is probably worth the try.

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