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Sheila Frame: The BPCIA's Impact on Industry


Sheila Frame, vice president and head of biopharmaceuticals, North America, at Sandoz, explains how the Biologics Price Competition and Innovation Act (BPCIA) has impacted the industry.


I think it's certainly the changes and the new regulatory pathway has certainly helped us as an industry continue to refine and move forward. I think there's some definite advantages for biosimilars in terms of what those hurdles actually are from a safety and efficacy perspective without at all compromising patient safety or what the true requirements are. I mean, the fact that we have to do comparative trials to demonstrate that there's no difference between the efficacy and safety that we have versus an originator across multiple batches, right, is pretty significant, and I think should lend a lot of credibility and confidence to the marketplace.

At the same time, I think we're still learning, right? So, from a drug development perspective, when you're looking at these kinds of investments, which are significant, I mean, we're running clinical trials like an originator would, I think that we're looking at things like how do we use extrapolation or do we have to do these trials around interchangeability that I think the FDA's still working on. How are we going to overcome some of those kinds of challenges?

And especially for the United States to be able to benefit from the simplicity of the European system, I think those are some of the things that we think could certainly add a great deal of policy information to speed along some of those changes. But for sure the openness in Washington right now to working with our industry to making sure that it's not a standard generic. It's not pill pressing. It is a biologic that requires the right kind of hurdles in order to make sure. And manufacturing these things, not easy, right? It's a very difficult process, and we take it very seriously. I think for Sandoz we're really lucky, because we have the benefit of our parent company as well as our own 35 years' worth of experience in this area. So we're certainly leveraging all of that, and then the openness to work with government in order to make it as smooth and as robust as we possibly can. So we're excited about the changes that have happened in the United States.

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