The US Food and Drug Administration’s (FDA) Office of Generic Drugs annual report reveals the importance of innovation and scientific collaboration in advancing the generic drug programme in 2021.
A statement released on 14 February 2022 by Dr Sally Choe, Director of the Office of Generic Drugs, provides a summary of the Office’s annual report for 2021.
The statement reveals that in 2021 FDA approved (or tentatively approved) 776 abbreviated new drug applications (ANDAs) for generic drugs. A further 108 pre-ANDA meeting requests were responded to regarding product development and/or pre-submission issues.
The agency understandably prioritized ANDAs for generic drugs which could treat COVID-19, with more than 75 original ANDAs for potential treatments or supportive therapies for COVID-19 being submitted to the agency.
A total of 1,787 complete response letters (CRLs) were issued in 2021, which detail the issues that applicants must resolve before FDA can grant approval.
The agency also issued 149 product-specific guidance’s (PSGs) for generic drug development, including 54 PSGs for complex drugs. PSGs are used by the agency to communicate the methodology and evidence needed to support the development of specific generics.
When it came to supporting research, the agency provided around US$20 million in funding to researchers for science and research into generic drugs. The agency also established the scientific foundation to support alternative bioequivalence (BE) approaches. This assisted the approval of several generics, including the first generic paliperidone palmitate extended-release injectable (generic invega sustenna), a long-acting injectable for schizophrenia, and the first complex generic for ferumoxytol injection (generic feraheme), a parenteral iron product used to treat anaemia .
Dr Choe’s statement also explains the importance of the FDA collaborations in 2021. She cites examples of collaborations with the University of Maryland and University of Michigan Center for Research on Complex Generics, which included workshops on the development of complex generics, reaching thousands worldwide.
FDA also joined forces with the European Medicines Agency (EMA) in 2021 to launch a joint pilot programme to provide parallel scientific advice to developers of complex generics, with the aim to reduce the time taken to approve such products.
Finally, the agency also continued its implementation of the Competitive Generic Therapy (CGT) programme, approving 100 ANDAs for CGTs in 2021. This programme aims to promote drugs with inadequate generics competition, which will increase the availability of generics in areas of the market that previously had limited competition.
Dr Choe ends the statement by emphasizing how the Office for Generic Drugs has continued to innovate and push the generic drug programme forward in 2021, despite the ongoing challenges of the COVID-19 pandemic.
She closes by saying: ‘As a results-driven organization, we engage the best experts, we emphasize best practices, and we translate research into actionable guidance. We are excited about the year ahead, and we anticipate a continuation of program growth throughout 2022’.
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1. GaBI Online - Generics and Biosimilars Initiative. Sandoz launches ferumoxytol and pemetrexed generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 1]. Available from: www.gabionline.net/generics/news/sandoz-launches-ferumoxytol-and-pemetrexed-generics
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