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Regulatory Approval Of Follow-On Biologics: Takings Implications Of Twelve Years Of Market Exclusivity And Future Conflict In Determinations Of Bioequivalence, Aileen Mcgill

Aileen M McGill

Congressional interest in the availability of low-cost pharmaceuticals has focused on the increasingly important class of drugs known as “biologics.” Biologics are protein-based pharmaceuticals derived from living matter or manufactured in living cells, which are more complex than the chemically synthesized molecules found in most pharmaceutical products. While there are many scientific differences between small-molecule pharmaceuticals and biologics, one of the most significant is the inability to reproduce them in generic form, creating a legislative division between generic entry for standard pharmaceuticals governed by the Hatch-Waxman Act and a similar approval process for “follow-on biologics” (FOBs). With the passage of …