USA – Complex Generic Drugs: FDA Offers Two Draft Guidances

The US Food and Drug Administration (FDA) on Tuesday unveiled one revised draft guidance and another new draft guidance to help advance the development of generic transdermal and topical delivery systems (TDS).

Applied to a patient’s skin, TDS products are expected to deliver the correct medication dose consistently and for the expected length of time while adhering consistently and uniformly to the skin, even if exposed to water, humidity and movement.

“Because of the inherent complexity of delivering a drug through a TDS, making generic copies of these complex drugs can be especially hard,” FDA Commissioner Scott Gottlieb said, noting that many TDS products like drug patches have not faced timely generic competition.

Other new policies to help complex generics include the development of “new analytical tools and in vitro tests that may be more accurate and sensitive, and reproducible tools to demonstrating sameness between a generic and branded version of a complex drugs,” he added. “We’ll also be issuing an umbrella guidance to help generic drug developers address some of the most challenging regulatory and scientific issues encountered when they try to make generic copies of complex drugs. This umbrella guidance will be followed by a series of more targeted guidances to help address legal questions that may be blocking generic competition.”

Irritation and Sensitization

This 12-page guidance provides recommendations for Abbreviated New Drug Application (ANDA) sponsors on the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery system (collectively referred to as TDS)…