RL33901
Follow-On Biologics
October 31, 2008

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Summary

This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of this report introduces innovation policy issues pertaining to follow-on biologics.

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