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Sheila Frame: Differences Between the US and European Biosimilars Markets


Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, addresses key differences between the US market and the EU market for biosimilars.


What are some of the key differences between the US market and the EU market for biosimilars?

I think one is experience, right? In the [United States]—I think the [United States] has always prided itself on being the leader in innovation.

And so, as a result of that, the policy environment has always protected innovation, much more so than in some of the other countries. So I think that's a fundamental difference, and I think it's an area that we absolutely need to continue to focus on. I think there's not a person in this industry who will say to you that innovation and protecting it isn’t important, and I'm a huge, passionate believer in patent and patent acts, trying to protect that innovation. Absolutely the inventor deserves to be protected and to benefit from the innovation, especially in healthcare where it benefits humankind.

Having said that, the World Trade Organization says 20 years, not 28 years, not 35 years, right? So, I think, as we look at this situation, Europe has very clean and specific policies as it relates to making the right balance between rewarding innovation and also the sustainability of the healthcare system. And I kind of feel like that's where we are with the US system today. We have to figure out a way to contribute to the sustainability of the system and make room for that innovation.

So, you know, as much as the FDA is there absolutely to protect the safety and wellness of people and of patients who ultimately take our products, I think we have this tremendous experience that we've had in Europe, where the conversion of the marketplace to biosimilars has not hurt anyone but actually benefitted not only patients but obviously the system as well.

So I think those are some of the learnings: clarity, simplicity of policy, and then this notion of it's not about being balanced between the originator and the biosimilar but rather actually enabling the uptake of biosimilars in order to create that space.

And then I would say finally, you know, in biologics, one of the things that patients often forget and we all forget, I think, the originator products that have been in the marketplace for 15, 20, 25 years, they actually are a biosimilar of themselves with every single batch. So biosimilars are not new. They're new maybe to the US market from the point of view of a Sandoz or another organization launching them, but within the originator companies, every batch is slightly different, and we certainly know that, because we sample them, right, in order to make that comparability, in order to get our own regulatory approval. So I think we just need to sometimes kind of keep that in mind.

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