FDA to Allow Biosimilar Makers to Use European Drug Samples

The FDA will close a loophole in the drug regulatory system by allowing U.S. drugmakers that create cheaper versions of expensive biologic drugs to use European drugs as a reference.

Scott Gottlieb, head of the Food and Drug Administration, says the agency is set to announce a “biosimilars action plan” on Thursday that will let biosimilar companies use samples of European biologics to create their generic counterparts. The proposed plan will have 11 points that “I think are going to create more competition in the market,” Gottlieb said at a PoliticoPro event July 17.

Right now, biosimilar companies that want ...