An approval pathway for generics was established in 1984 based on the Hatch-Waxman Act (formally the Drug Price, Competition and Patent Term Restoration Act). At the time, experts estimated that generics could save the healthcare system as much as $1 billion dollars per year. Today we know that generics have saved the healthcare system approximately $1 trillion dollars since their approval. Much has changed in the pharmaceuticals marketplace since 1984. Perhaps the biggest change has been the introduction of complex large molecule injectable therapies (biologics) such as the erythropoiesis stimulating agent Epogen, anti-cancer therapies Herceptin and Avastin, and a host of other inflammation blockbusters, including Enbrel and Humira. Evaluate Pharma, a source for pharma and biotech analysis, estimates that sales of biologics will eclipse sales of small molecule drugs by 2014.

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