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Scott Gottlieb, MD: Phase 3 Trials and Biosimilars


Scott Gottlieb, MD, former commissioner of the FDA, discusses whether phase 3 trials for biosimilars might eventually be waived in the United States.


Well, the process for developing a biosimilar and getting it through the development process is fairly efficient. It’s costly—biosimilar manufacturers will say it will cost anywhere from $100 million to $300 million to develop a biosimilar. A lot of those costs aren’t necessarily the clinical trials, but the cost of actually developing the biosimilar. It’s not a trivial process. The manufacturing cost is substantial. You have to make a big investment in manufacturing when it comes to a biologic.

I think there are ways to continue to make the development process more efficient, in terms of the kind of clinical information that’s required through the regulatory process. I don’t think you’d ever eliminate it. I think there’s always going to be a need to do some level of clinical evaluation and have some component of clinical trials in order to prove the similarity or sameness of the biosimilar to the incumbent biologic, but I think that there are ways to continue to make that process more efficient.

But once again, I don’t think that toggle isn’t going to dramatically change the value proposition and the opportunities when it comes to biosimilars. I think where we’re going to have the most ability to try to move the needle, when it comes to biosimilar adoption, is more on the commercial side.

Physician adoption, physician acceptance, educating doctors about biosimilars, looking at some of the structures in the market that create impediments to biosimilars launching into the market effectively, like the existence of rebates on the incumbent biologic.

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