How can a company obtain faster Marketing Authorization for a generic, non-biologic product after the data exclusivity period has ended?

A company can obtain faster Marketing Authorization for a generic, non-biologic product after the data exclusivity period has ended by conducting bioavailability and bioequivalence studies. This is essential because bioequivalence studies demonstrate that the generic product performs similarly to the reference product, ensuring that it is therapeutically equivalent for patients. Regulatory authorities often rely on these studies to expedite the approval process, as they show that the generic can safely and effectively replace the branded drug without the need for further extensive clinical trials.

While eliminating the need for clinical studies may seem advantageous, it is typically not a path available for every situation, especially if specific clinical data are required for safety or efficacy validation. Referring only to published literature isn't sufficient for proving bioequivalence; regulatory bodies usually mandate specific studies to support the application. Submitting a request for accelerated review might be an option in certain circumstances, but it is not a guaranteed route for all generic drug applications, especially if standard bioequivalence criteria have not been met. Therefore, the most reliable and typical approach for faster authorization remains through bioavailability and bioequivalence studies.