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Sheila Frame: Biosimilars and the Policy Environment


Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, discusses policy challenges related to biosimilars.


In terms of the policy environment, in the last few months we've seen some big shifts, right? So Medicare Part B was a pretty significant concern for us with shared J-codes, because you weren't able to really manage that average selling price. So now that we have the legislation and the regulations that were changed where every biosimilar will have its own J-code, that certainly has made it a lot easier.

But it hasn't made it easier than the reference product for us. So I kind of feel like we're on a level playing field, whereas we weren't before, but I would argue that maybe we actually need to move beyond a level playing field in order to facilitate this uptake.

The second area is Medicare Part D. We had a significant issue where we were actually by law prevented from supporting patients through the doughnut hole where now that got changed in the budget changes at the end of January. And so we're certainly excited about that opportunity, but at the same time we're just on a level playing field, and we haven't yet been really enabled to be facilitated, I guess, that true uptake, and I think that's where the benefit is.

Now, at the same time, if you listen to Scott Gottlieb, he's talking about pretty significant policy reforms that we know they're looking at and that we continue to work with them on. I do think that there's kind of 2 issues.

There's a patient and a market confidence issue as we bring these products to market. There is the patent situation, and then finally there's the rebate wall. So, when you're going up against these massive products, I think it's really incumbent on the biosimilar companies to try to really deeply understand how we can work better within the system from a contracting perspective, and transparency, in order to really make that uptake happen much more quickly.

So, when you compare the US market to the rest of the world, everybody's going like, "What's taking you guys so long?" Right? So, what is taking us so long?

There are some disincentives, for sure, in the current structure of the system. At the same time, I couldn't be more excited about the amount of energy around trying to make this happen in order to make sure that our system is sustainable. It's critical for the future of the [United States] to make sure that we have a sustainable healthcare system.

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