Usuario:ZacheryMcAdams

Introduction: All the above five products named, most of Amgen's more junior products, and most of its pipelines are approved not via the NDA process used for oral drug products but as biologics, via a BLA. As proteins which cannot be dosed orally but must be injected, they are not subject to direct generic competition via the traditional 505(j) based ANDA pathway specified by the "Hatch Waxman Act" of 1984. And in Europe, a copycat version must be approved via a much more expensive route, ending up with a "biosimilar" product that requires marketing rather than simply relying on pharmacies to automatically substitute a cheaper ANDA based generic for the brand..

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