FDA Issues Draft Guidances for Complex Generic DrugsBy
As part of the US Food and Drug Administration’s (FDA) efforts to promote drug competition and patient access, the agency has issued two draft guidances to advance the development of complex generic drugs. Complex generics are drugs that, by nature of their formulation or delivery systems, for example, are harder to “genericize” under traditional approaches.
“Today [October 9, 2018], we’re announcing a series of guidance documents that will advance the development of generic transdermal and topical delivery systems (TDS),” FDA Commissioner Scott Gottlieb said in an October 9, 2018 agency statement. “The increased transparency and predictability provided by these and other product-specific recommendations gives applicants seeking to develop generic copies of these complex products a better opportunity to efficiently advance these products and prepare better and more complete submissions.”
TDS products are applied to a patient’s skin and deliver the drug into and through the skin. “Because of the inherent complexity of delivering a drug through a TDS, making generic copies of these complex drugs can be especially hard,” said Gottlieb in his statement. “As a result, many branded TDS products like drug patches have not faced timely generic competition.”
The two draft guidances include the revised draft guidance, Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs, which provides updated advice for the design and conduct of studies evaluating the adhesive performance of a proposed generic TDS. A second draft guidance, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs, provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization potential of a proposed generic TDS.
In addition to these draft guidances, the FDA is also issuing 25 product-specific draft guidance documents. These include two new and 23 revised guidances. These guidances will support industry in identifying appropriate science-based methodologies and evidence for developing generic TDS products. The FDA says it will also be issuing an umbrella guidance to help generic-drug developers address some of the most challenging regulatory and scientific issues encountered when trying 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.
“Being able to ‘genericize’ a complex drug can be a high-value opportunity for a generic drug developer,” Gottlieb said in his statement. “These higher value generic business opportunities can help underwrite the costs of other generic applications at a time when we believe the generic industry is facing new economic pressures from rising costs, supply chain consolidation, increased competition and declining reimbursement on many competitive generic medicines.”
The FDA says it will also develop new analytical tools and in vitro tests that may be more accurate and sensitive, as well as reproducible tools to demonstrate sameness between a generic and branded version of a complex drugs.