The BCPIA provides an abbreviated pathway for the licensing of biological products that are biosimilar to or interchangeable with a previously licensed biological product (“reference product”).
The BCPIA is analogous to the Hatch-Watchman Act, which provided an abbreviated pathway for the approval of generic versions of brand-name, chemically synthesized drugs, decreasing the time it took for generics to get FDA approval and providing the U.S. consumer with rapid access to lower-priced alternatives to brand-name drug.
But where the Hatch -Waxman Act applies to generic drugs, The BCPIA applies to biologics.
The BCPIA is analogous to the Hatch-Watchman Act, which provided an abbreviated pathway for the approval of generic versions of brand-name, chemically synthesized drugs, decreasing the time it took for generics to get FDA approval and providing the U.S. consumer with rapid access to lower-priced alternatives to brand-name drug.
But where the Hatch -Waxman Act applies to generic drugs, The BCPIA applies to biologics.
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