Scott Gottlieb, MD, former commissioner of the FDA, discusses whether Congress should make changes to the Biologics Price Competition and Innovation Act (BPCIA) if the opportunity arises.
I think Congress struck the right balance. I think that Congress gave enough flexibility to the regulatory authorities, including FDA, to try to continue to evolve the biosimilar pathway.
I think in terms of the data protection that was provided, it was the right balance to create incentives to continue to invest and innovate while still creating an entry point for lower-cost competition.
I think that the challenge now is continued regulatory improvement to try to make the process more efficient and lower cost so you see more entrants and maybe get the cost down developing a biosimilar, but also looking at some of the commercial challenges and the reasons why we don’t see fast ramps, and we don’t see as much physician adoption as we probably should given the rigorous process that these products go through and the value that they have the potential to deliver.