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Sheila Frame: Therapeutic Areas That Need Biosimilars


Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, discusses which therapeutic areas need biosimilars the most.


Are there some therapeutic areas where biosimilars are must urgently needed in the US market?

I would have to start with the most urgent need is in the immunology space. That's where the innovation is happening, right? We know immune oncology, gene therapy, all these things that are happening, and more so in the oncology space to treat cancer, which is a pretty significant challenge from a healthcare perspective.

But we have these products and these biologics that have been in the market now for 20 years. We have an approved biologic for rheumatoid arthritis that's been approved by the FDA since 2016. And we still haven't been able to launch it.

So I think that's probably where the biggest opportunity is. You see these massive products that are $14, 16 billion a year that even if you assumed that a biosimilar coming to the market could save you 15% to 20%, that is tremendous value to put back into the healthcare system in the [United States].

So I think that's probably the biggest area, if you think about immunology and then oncology at the same time as all of this incredible innovation is happening. Who could have imagined just a few years ago that you can actually get people suffering from lung cancer to actually have survival? Melanoma, right, we now have these mega curves in survival. Well, in order to be able to make those products accessible, then we have to absolutely take advantage of what biosimilars bring to the marketplace.

And then finally I would just say how many people in the [United States] don't get access to a biologic because they simply can't afford it? And I think that's part of the promise of biologics. We know that the sooner you treat someone who's suffering from an immunological disease, the sooner you treat them the more likely you're going to be to avoid the long-term effects of that and actually give them a better quality of life.

So I think those are the 2 benefits. There's the cost benefit, but then there's also the opportunity for people who might otherwise not be able to access these medications.

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