Follow-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. Given the nature of… (More)
DOI: 10.1038/nrd2532


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