Nature reviews. Drug discovery
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Nat Rev Drug Discov · Jun 2008
ReviewFollow-on biologics: data exclusivity and the balance between innovation and competition.
Legislation to create a regulatory pathway for follow-on biologics is currently being considered by the United States Congress. A critical issue in this respect is the period of data exclusivity for innovator companies before a follow-on competitor can rely in part on data obtained for an original biologic for an abbreviated approval. ⋯ With this issue in mind, this article discusses factors influencing return on investment on biologic research and development. A break-even analysis for a representative portfolio of biologics provides support for a substantial data exclusivity period.