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MoFo Tech A blog dedicated to information, trend spotting & analysis for science- & tech-based companies

Tag Archives: Hatch-Waxman Act

Jumping the Line

Generic drug makers aren’t waiting until patents expire Since passage of the Hatch-Waxman Act in 1984, generic drug companies have used its Abbreviated New Drug Application (ANDA) process to bring cheaper versions of brand-name drugs to market after their patents expire. In the past decade or so, generic drug companies have commonly applied for the… Continue Reading

Biosimilars: On a Different Path

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