BY: PHILIP KUEHL
Throughout the pharmaceutical product development cycle, development teams are continually working to reduce the time to market while maintaining product quality and adhering to budgets. A reduction in time to market results in treatment benefits to the intended patient population sooner, a reduction in the overall development cost, and the ability of the development teams to move on to the next product development opportunity. The generic product development teams also work to reduce time to market in order to provide the same treatment benefits to patients as the innovator products provide, but at a reduced cost to the patient.
The majority of drug products are protected by patents for many years after they are approved for marketing. Patent protection means that patients don’t have the option of receiving a generic product until after the branded product patent expires. The complexity of inhalation products has contributed to the difficulty in generic product development and thus a lack of generic product competition for years beyond the innovator product patent expiration.
In an effort to reduce the cost of medications and set bioequivalence expectations for generic inhalation products, the Food and Drug Administration (FDA) has issued guidances for specific products (i.e., FDA draft guidances on Fluticasone Propionate: Salmeterol Xinafoate DPI, Albuterol MDI, Budesonide Inhalation Suspension, etc. to aide generic product development. The European Medicines Agency (EMA) and Brazil’s National Health Surveillance Agency (ANVISA) have also set in place expectations to demonstrate bioequivalence between reference listed and generic products as well. Differences exist between the outlined approaches. While EMA provides a pathway for approval based on a stepwise evaluation of parameters (e.g., in vitro similarity or pharmacokinetic similarity or pharmacodynamic similarity), FDA and ANVISA use a weight of evidence approach in which similar in vitro as well as similar in vivo data are required for approval.
In order to bring together inhalation scientists from academia and industry and regulatory officials, the AAPS Inhalation and Nasal Technology focus group (INTFG) is excited to announce the upcoming meeting Review of Regulatory Issues and Strategies in the Development of Generic Inhaled Products. This symposium is designed to generate scientific discussions around strategies that have been employed and how/what improvements can be made. This meeting will be hosted by Merck & Co. in Rahway, N.J., on September 16, 2016. The organizers, INTFG, and AAPS hope you consider attending this fall symposium and hope you bring scientific questions and ideas with you for discussion.