AAM ‘Appreciates’ Sameness Evaluation Guidance

The Association for Accessible Medicines (AAM) says it appreciates FDA issuing a draft guidance with recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference-listed drug. “The draft guidance effectively consolidates various policies we’ve seen in other documents or heard from FDA in verbal or written feedback,” an association comment letter says.

AAM says it believes there is an opportunity to provide additional details that will help manufacturers better understand FDA’s preferences for demonstrating sameness. It recommends the agency consider adding an appendix or issuing additional guidance containing examples of design preferences of sameness studies for specific drugs or categories of drugs and explanations as to why a particular study design, although not required, may be preferred by the agency in each case.

The letter contains additional recommendations and requests for clarification.