U.S. Senator Mike Enzi, R-Wyo., spoke to President Donald Trump’s pick to head the Food and Drug Administration (FDA), Scott Gottlieb, MD, today about aligning drug approvals with advances in science, access to drugs, as well as needed improvements in the biosimilar approval process.

During a Senate Health, Education, Labor and Pensions Committee hearing for Gottlieb’s nomination, Enzi emphasized the importance of removing unnecessary barriers to approval of novel drug treatments. Enzi also stressed the importance of the FDA in ensuring that people understand that drugs approved under accelerated review are held to the same approval standard and are not considered investigational.

“There is some sense outside of FDA that accelerated approval does mean a lesser standard,” Enzi said. “This is concerning as it can impact patients and their access to these drugs.”

Enzi also mentioned the importance of follow on biologic drugs or biosimilar drugs, and raised concerns that the FDA has been slow in implementing the approval biosimlar pathway in law. Biosimilars are therapeutic drugs that are similar but not identical to brand-name biologics, which are drugs or vaccines made from living organisms.

“Since the launch of the Biosimilar User Fee Agreement in 2012, there have been four approvals. However, only two have made it onto the market,” Enzi said. “By 2021, there will be more than 70 biologic agents coming off of their patent protection, and there could be a significant amount of activity in the biosimilar space.”