The scientific, regulatory, and legal framework for the approval of small-molecule generic drugs is well developed. Generic drugs are defined as products containing the same active ingredient as the branded drug, but likely having different inactive ingredients. In order to be marketed, the generic drug must have the same quality, efficacy, and safety as the branded drug. In contrast, marketing requirements for generic biologics, or follow-on biological products is unknown.

Many biologics, including blockbusters like Epogen/Procrit, are nearing patent expiration, and generics manufacturers, including Sicor (acquired by Teva), Barr Laboratories, and Ivax Corporation, are hoping to market generic biologics. Follow-on biologics, such as insulin, human growth hormone, and granulocyte-colony stimulating factor already have been marketed in third world nations....

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