A Pathway to Follow-On Biologics

by Jeanne Yang –
Biologics are rapidly growing in importance in the medical world.  The ability of biopharmaceutical drugs to replace natural proteins produced by the body make them invaluable as therapy regimens to target major disease including cancer, infectious agents, and a variety of other health conditions  Consideration of the current drug approval system (the Hatch-Waxman Act) and the available options for a regulatory pathway for generic biologics (Waxman’s and Eshoo’s Bills) reveals that the bills currently pending before Congress still need revision.  Specifically, considering the importance of biologics as a growing field of medicine that treats many medical ailments, Congress should ensure an abbreviated approval process for follow-on biologics.  An abbreviated process with a mandatory one year clinical testing period that requires a follow-on biologic to be the same as its reference biologic would be the best option to address the issues currently facing biologics.

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