Bioequivalence studies play a crucial role in drug development as companies pursue line extensions, make manufacturing changes, develop generic drugs and seek US Food and Drug Administration (FDA) approval via the abbreviated drug approval pathway known as 505(b) (2). This drug approval pathway relies upon “at least some of the information from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference,” helping the sponsor win approval of a new strength, new dosage form or new route of administration for an existing drug without the time and cost of duplicating safety and efficacy studies previously conducted by the innovator company. The sponsor of a 505(b)(2) application in these scenarios would need to demonstrate bioequivalence of the new dosage form, route of administration, etc. to the referenced product that was previously approved by FDA.

Regulatory Focus 15:8:42–44, 2010