Will Hogan Indeed, this was the goal of the Drug Price Competition and Patent Term Restoration Act (commonly known as the Hatch-Waxman Act). The idea was to create incentives for makers of biosimilars and non-infringing substitute drugs to do the necessary FDA approval work (bioequivalence tests) in exchange for some exclusivity (as the first generic producer) in the market.  The patent terms of the original drug manufacturers were also extended to compensate them for time lost while the patent was valid, but the FDA approval not obtained.

Will Hogan Indeed, this was the goal of the Drug Price Competition and Patent Term Restoration Act (commonly known as the Hatch-Waxman Act). The idea was to create incentives for makers of biosimilars and non-infringing substitute drugs to do the necessary FDA approval work (bioequivalence tests) in exchange for some exclusivity (as the first generic producer) in the market.  The patent terms of the original drug manufacturers were also extended to compensate them for time lost while the patent was valid, but the FDA approval not obtained.

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