FDA Looks to Advance Complex Generics

On January 30, 2019, FDA Commissioner Scott Gottlieb, MD announced the agency would be publishing a series of guidance documents to address the specific challenges involved in the development of generic versions of complex drugs.  These guidance documents will be part of the agency’s Drug Competition Action Plan.

According to FDA, complex drugs are often harder to develop and manufacture because of either their complex formulation, complex active ingredient, or administration (i.e., those administered topically, inhaled, or in the eye). Developing generic copies of these drugs and formulations can, therefore, be difficult. FDA plans on addressing these challenges by creating policies specific to these problems, writing guidance documents for developing specific complex generic drugs, and addressing “categories of complex drugs that are hard to copy because of their complex formulation or mode of delivery.”  The new guidance documents will include recommendations on establishing active ingredient sameness and the development of new analytical tools and in vitro tests for complex generic drugs.

“These new policy efforts are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs. This focus is critical because, first and foremost, these drug products provide important therapies to patients. We believe that they’re also becoming increasingly important to the economic stability of the generic drug industry. Being able to “genericize” a complex medicine can be a high-value opportunity for a generic drug developer,” Gottlieb stated.

Source: FDA