FDA issues guidance for developers of complex generics

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The US Food and Drug Administration (FDA) announced on 9 October 2018 that it had released new guidance documents as part of its efforts to advance the development of generics of complex drugs with the aim of improving patient access to medicines.


FDA defines complex products as including products with complex active ingredients, formulations, routes of delivery or dosage forms; complex drug-device combination products; and other products where complexity or uncertainty concerning the approval pathway or possible alternative approach would benefit from early scientific engagement.

The agency has released a series of guidance documents that it says, ‘will advance the development of generic transdermal and topical delivery systems (TDS)’.

The new guidance documents include:

Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs
Date: October 2018

The revised draft guidance provides updated advice for the design and conduct of studies evaluating the adhesive performance of a proposed generic TDS.

Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
Date: October 2018

This draft guidance provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization potential of a proposed generic TDS.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 documents, FDA has also issued 25 product-specific guidance documents. These include two new and 23 revised guidances. These documents, according to the agency, ‘will support industry in identifying appropriate science-based methodologies and evidence for developing generic TDS products’.

Product-Specific Guidances for Generic Drug Development
Date 1 October 2018

The draft guidances are aimed at ensuring that FDA provides as much scientific and regulatory clarity as possible with respect to complex generics.

FDA Commissioner, Dr Scott Gottlieb, said that ‘in too many cases, there is no generics competition for these costly branded drugs even after they have lost their exclusivity protections’. In July 2017, FDA published a list of brand-name drugs that no longer have patent protection or exclusivity in the US and that do not have approved generics with the aim of increasing competition and encouraging the entry of generics in the US [1]. The agency has also released guidance outlining how sponsors can qualify for shorter review times for priority generics [2].

FDA also says that it intends to advance other new policies in the coming months to promote more generic competition for complex drugs. This includes 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 brand-name version of a complex drug.

Related articles
FDA releases product-specific guidance to increase generics competition

FDA trying to reduce hurdles for complex generics

1. GaBI Online - Generics and Biosimilars Initiative. FDA lists drugs without generics to increase competition [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Generics/General/FDA-lists-drugs-without-generics-to-increase-competition
2. GaBI Online - Generics and Biosimilars Initiative. FDA to speed up review of priority generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 9]. Available from: www.gabionline.net/Guidelines/FDA-to-speed-up-review-of-priority-generics

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Source: US FDA

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