― Brand-new FDA guidelines have created a long-awaited shortcut for bringing biosimilars—cheaper versions of biologically derived pharmaceuticals—to the U.S. market. But the pathway won’t be nearly as straightforward as the one for generic versions of less complex, chemically based drugs that was created under the Hatch-Waxman Act in 1984. Unlike the Hatch-Waxman route, the biosimilar guidelines... Continue Reading .
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