The 1984 Hatch-Waxman Act created a streamlined path for generic drugs to reach the market after pioneer drug patents expire. The result has been the most vigorous and competitive generic drug market in the world, but the Hatch-Waxman Act does not apply to most biologics. Isolated from a variety of natural sources (human, animal, or microorganism), biologics are produced by biotechnology methods or other cutting-edge technologies, and unlike common small-molecule pharmaceuticals, these new drugs generally have a high molecular complexity which may be sensitive to changes in the manufacturing process. Newer biotech biologics are responsible for revolutionizing the treatment of cancer and rheumatoid arthritis among many other diseases.
Because follow-on biologics--drugs that follow the original pioneering ones--are grown through biological processes rather than manufactured in the traditional sense, they pose special difficulties for approval and safe use. Panelists at this conference will discuss regulation (including in Europe, which already has a follow-on biologic pathway), manufacturing, economics, and intellectual property.
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