FDA plans to advance development of complex generics in 2019

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In a statement released on 30 January 2019, US Food and Drug Administration’s (FDA) Commissioner Scott Gottlieb outlined the steps FDA will take in 2019 to promote access to complex generic medicines.


The framework for generic drug review was developed under the Hatch-Waxman Amendments in 1984, a time when branded drugs were often simple, small molecules with uncomplicated and reproducible manufacturing processes. By contrast, complex medicines include products with complex active ingredients, formulations, routes of delivery or dosage forms, and they are difficult to develop and manufacture under traditional approaches. Therefore, it is more difficult for complex medicines to meet the standards for generic drug approval.

FDA recognizes that there are a number of complex medicines that are no longer protected by patents or exclusivities that would prevent generics approval, yet they continue to face no generics competition. To address this, FDA plans to advance policies to promote generics competition for complex drugs by providing as much scientific and regulatory clarity as possible. This will include publishing a series of guidance documents to address regulatory and scientific challenges that make it harder to develop complex generics, including recommendations on establishing active ingredient sameness. In addition, FDA intends to advance the development of new analytical tools and in vitro tests to support approval of complex generics by reducing drug development time and cost. These plans follow the release of a series of FDA guidance documents in October 2018 that aim to advance the development of generic transdermal and topical delivery systems [1].

In the recent statement, Commissioner Scott Gottlieb says, ‘We believe that [complex medicines are] 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’.

FDA has also issued new guidance for its novel accelerated pathway for generics – the Competitive Generic Therapies (CGT) pathway [2]. These recent policy efforts aimed at promoting more generics competition are a key part of FDA’s Drug Competition Action Plan, and the agency’s efforts to promote patient access and more affordable medicines.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA issues guidance for developers of complex generic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 8]. Available from: www.gabionline.net/Guidelines/FDA-issues-guidance-for-developers-of-complex-generics 
2. GaBI Online - Generics and Biosimilars Initiative. FDA issues new guidance for accelerated pathway for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 8]. Available from: www.gabionline.net/Guidelines/FDA-issues-new-guidance-for-accelerated-pathway-for-generics

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Source: US FDA

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