FDA announced on 11 January 2021 that it had published its Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report. The report outlines topics that FDA has identified as needing continued targeted investment in regulatory science research to facilitate the development of innovative products, provide data and methodology to inform regulatory decision-making and improve guidance to sponsors. Each FARS aligns with one of four strategic initiatives: Public Health Preparedness and Response; Increasing Choice and Competition through Innovation; Unleashing the Power of Data and Empowering Patients and Consumers [1].

As part of FDA’s focus on Increasing Choice and Competition through Innovation FDA has included its ongoing work to try to increase access to generic alternatives for complex drugs.

The agency has included the development of generic versions of complex drugs as one of its focus areas ‘because they represent nearly one-third of drug products currently used but have less generic competition than non-complex drugs’. However, this is not the first time FDA has focussed on complex generics. At the beginning of 2019, then FDA Commissioner Scott Gottlieb outlined plans to promote access to complex generics [2]. This included a workshop on complex generics [3] and updated guidance for manufacturers [4].

According to FDA, ‘the presence of generics on the market helps to ensure availability of quality medicines at a lower cost to the American public’. The agency says that is why it prioritizes research to develop methods and approaches for establishing the bioequivalence of generics of complex drugs.

FDA uses bioequivalence data in its review of applications and has developed guidance documents for makers of complex generics [2]. Factors considered by FDA when determining whether drugs are complex include size of the molecule and mixtures of active or inactive components or formulations. The agency 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 released guidance documents for complex generics using transdermal and topical delivery systems back in 2018 [5] and issued new and revised guidances for complex generics in November 2020 [6].

FDA adds that ‘evaluations of complex generics often require advanced analytical technologies to properly assess quality attributes critical and advanced quantitative methods and modelling and data analytics methodology to establish scientific standards that would ensure therapeutic equivalence in patients’.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA publishes report on areas of regulatory focus for 2021 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Reports/FDA-publishes-report-on-areas-of-regulatory-focus-for-2021 
2. GaBI Online - Generics and Biosimilars Initiative. FDA plans to advance development of complex generics in 2019 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Guidelines/FDA-plans-to-advance-development-of-complex-generics-in-2019 
3. GaBI Online - Generics and Biosimilars Initiative. FDA organizes workshop on complex generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Guidelines/FDA-organizes-workshop-on-complex-generics 
4. GaBI Online - Generics and Biosimilars Initiative. FDA planning more guidance for developers of complex generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Guidelines/FDA-planning-more-guidance-for-developers-of-complex-generics 
5. GaBI Online - Generics and Biosimilars Initiative. FDA issues guidance for developers of complex generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Guidelines/FDA-issues-guidance-for-developers-of-complex-generics 
6. GaBI Online - Generics and Biosimilars Initiative. FDA new and revised guidances for complex generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Feb 5]. Available from: www.gabionline.net/Guidelines/FDA-new-and-revised-guidances-for-complex-generics

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