Equivalence of complex and locally-acting products in GDUFA Science Priorities for 2017

The final year of the first Generic Drug User Fee Act (GDUFA I), FDA’s Office of Generic Drugs (OGD) lists the following priorities:
• Post-market evaluation of generic drugs
• Equivalence of complex products
• Equivalence of locally-acting products
• Therapeutic equivalence evaluation and standards
• Computational and analytical tools.

Of particular interest to generic drug manufactures and regulatory professionals is the planned research into the equivalence of complex drug products and locally-acting drugs.

In the future, generic products will need to show equivalence to increasingly complex RLDs such as drug-device combinations, transdermal systems, implants and parenteral microspheres, nanomaterials (e.g. liposomes and iron colloids), and products that contain complex mixtures and peptides. New guidance may be forthcoming on transdermal irritation studies and human factors studies aiding the evaluation of product substitutability and robustness for drug-device combinations.

The absence of efficient bioequivalence pathways for locally-acting drug products has limited the development of generic drugs in this category. Proposed research will look into new bioequivalence methods and pathways for locally acting drugs, including inhalation, topical dermatological, nasal, ophthalmic, gastrointestinal, and otic drug products. This research priority includes evaluating in vitro alternatives to clinical endpoint bioequivalence studies.

Click here to read the FDA report.