FDA Provides Generic Approval Roadmap for 38 Drugs, Including Vertex's Kaldeco

The US Food and Drug Administration (FDA) has announced the release of new documents meant to make it easier for generic manufacturers to introduce competition to 38 existing drug products, including popular new drugs like Stendra, Belviq, Kalydeco and Brilinta.

The documents, known as bioequivalence recommendations, specifically apply to the Abbreviated New Drug Application (ANDA) process—the process by which generic drugs are approved.

Generic drugs, unlike new drugs, may be approved by FDA by showing that they are (among other things) bioequivalent to the drug they intend to reference. Bioequivalence can be shown in relatively small trials involving human subjects, which permits a company to avoid much larger—and much more expensive—full clinical trials required of new drug substances.

The bioequivalence guidance documents released by FDA last week explain how each generic drug company can test its products to ensure they pass FDA muster. Each document contains a list of recommended studies (typically at least two), the characteristics of each study, the standard for bioequivalence that must be met by each generic product and potential waivers a generic company may apply for.

The documents are, in effect, a roadmap for regulatory approval for generic drug companies. The publication of a bioequivalence document does not, however, indicate that FDA will approve a generic drug product immediately. Patent and marketing exclusivity protections may still be in effect, which can preclude FDA approval or market access.

New Bioequivalence Guidance Documents

The new documents, along with a list of the brand name drugs they reference, are as follows: