Bioequivalence and Bioavailability Forum

Dear Mr Chirag,

In his response to Teva's second citizen petition, FDA asserted its ‘broad discretion’ in determining whether the submitted information (conventional bioequivalence study) is enough to conclude that the generic product is the same as the original. The agency also stated that it may require a generic company to prove sameness "although we cannot state with any certainty what these criteria may be. A finding of sameness does not, however, necessitate a finding of ‘complete chemical identity’. Thus, the agency may consider other criteria to determine sameness, taking into account the complexity of the active ingredient.

Hence, you can conduct bioequivalence study for ANDA, however, it is upto FDA to give final nod on the approval of bioequivalence study.