Bioequivalence and Bioavailability Forum

❝ ..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.

Decision by the FDA might be available as early as May 2014. Good luck with BE-study (and some good lawyers, too, maybe?)

Regards


btw: Strange that for a chemically undefined compound with parenteral application mode a BE study should provide meaningful data to support therapeutic equivalence for an ANDA...