How are Changing Policies Supporting Biosimilar Development, Approval?


Ron Lanton III, Esq., President, True North Political Solutions, touches on some policies that are changing and may support biosimilar development.

Lanton: There are a lot of policies out there supporting biosimilar development. I think everything started with Hatch-Waxman. I know that’s an old thing and it started with generics, but without that law, you wouldn’t have the biosimilar law that came in 2009.

It was the Biologics Price Competition and Innovation Act of 2009. That actually gave rise to a pathway for biosimilars, so they followed that.

Of course, right now in Congress, you have 2 bills that are focused on biosimilars, trying to get them to the market faster. So, that’s the first thing.

The second thing that we’ve had for favorable environment for biosimilars is with the regulatory process. We’ve had the FDA—even though we want more information from the FDA—they’ve at least come out and talked about interchangeability and they’ve talked about suffixes and both of those guidance documents have a little further to go, but at least they’re thinking about it because they want it out there.

The last thing is the court system. We recently had a case of Amgen vs. Sandoz. Big thing, everyone was watching for it and that ruling actually produced a favorable result for biosimilars.

You can see from courts to Congress to the regulatory environment, there’s quite a lot of favorability because the promise of biosimilars coming to the market produces lower prices and we’ll see how that works.

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