Differences and similarities between generic drugs and their originator counterparts l Hatch-Waxman Act

 

                                                        

Differences and similarities between generic drugs and their originator counterparts/ Brand-name counterpart (Innovator Products)

Generic medicines are those where the original patent has expired (or if the patents are successfully challenged by the generic drug company), and which may now be produced by manufacturers other than the original innovator (patent-holding) company.

The 1984 Drug Price Competition and Patent Term Restoration Act (more commonly known as the Hatch-Waxman Act) in the US allowed for an abbreviated system for approval of generic copies of all drugs approved after 1962, meaning that pre-clinical and clinical testing did not have to be repeated for generics. The intended result of this legislation was to ensure that generic medicines would be less expensive than the equivalent originator medicine because it was not necessary for generic medicine manufacturers to repeat discovery, pre-clinical and clinical studies.

Originator (New Drug Application - NDA) versus Generic (Abbreviated New Drug Application - ANDA) Review Process Requirements for a comparison of the originator versus generic medicine review process.

    NDA Requirements                                       ANDA Requirements

    1. Labelling                                                       1. Labelling

    2. Pharmacology/ Toxicology                           2. Pharmacology/ Toxicology

    3. Chemistry                                                     3. Chemistry

    4. Manufacturing                                               4. Manufacturing

    5. Controls                                                         5. Controls

    6. Microbiology                                                 6. Microbiology

    7. Inspection                                                      7. Inspection

    8. Testing                                                           8. Testing

    9. Animal Studies                                             9. Bioequivalence 

    10. Clinical Studies

    12. Bioavailability 

     Note: Pre-clinical and clinical testing did not have to be repeated for generics

To gain FDA approval, a generic medicine must:

 

·       Contain the same active ingredient as the originator medicine (inactive ingredients may vary)

·       be identical in strength, dosage form, and route of administration

·       have the same use indications

·       be bioequivalent

·       meet the same batch requirements for identity, strength, purity, and quality

·       be manufactured under strict standards of FDA's good manufacturing practice regulations