Carol Lynch: Barriers to the US Biosimilars Market

Carol Lynch, president of Sandoz US and head of North America, discusses the barriers blocking market access for biosimilars in the United States. 
February 08, 2019


What are some barriers that are blocking market access to biosimilars in the United States?

Well, in order to be able to commercialize a product, first of all, you need to get regulatory approval, and I think we’re doing pretty okay there. If you look at the number of approvals in the [United States], it’s definitely catching up. Still behind Europe, but definitely catching up. Then you need to be able to launch.

If you look at the number of approvals, which today is 17, and yet only 5 of those products are actually being marketed today. So clearly, we’ve got an issue once we’ve had approvals to get to market, and I think that’s where the litigation barriers come in.

Then, once on market, if you look at the performance of the various products that have been launched, then you see quite an inconsistency.

Our own Zarzio was launched more than 3 years ago and has performed, I think, according to expectations of a biosimilar in a developed market. We have achieved leading market share by volume within 3 years of launch, overtaking the originator, so I would say that is a successful biosimilar. But we don’t necessarily see that across all of the brands that have been launched. So, I think there’s still some inconsistency there, and one of the major barriers is actually around the contracting and rebating practices we see from some of the originator companies.

So clearly, still a number of barriers to be taken down in order to have a vibrant biosimilar healthcare system in the [United States].


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