How Can Emerging Laws Help the Biosimilar Market Thrive?


Ron Lanton III, Esq., President, True North Political Solutions, speaks about proposed legislation that could bolster the emergence of biosimilars.

Well, I think emerging laws can help them thrive in a number of different ways. Obviously, the Amgen/Sandoz case, from a judicial perspective, cemented a lot of things. What I think is going to be interesting about that is we’ve had the federal government file an amicus brief on that case, which said that even though the case has been remanded to the state of California, because states have different patent laws, the federal government is saying that you should take that out because it’s preemptive. So, if they do get there way, then that case is settled, again biosimilars are favored.

Other emerging laws, the Fast Generics Act and the CREATES Act, both of those bills currently at congress, they have a lot of support because people want to lower drug prices, and I think that’s the direction that we’re going, and we’re kind of in a wait and see approach. We’ve got the guidance that’s coming up from the regulatory agency of the FDA. We’re just going to see how fast that goes, and whether the FDA administrators drug competition plan has anything to do with biosimilars. Right now, it’s focused on generics, but we can see that morphing into biosimilars and creating some exciting policy opportunities.

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