The US Food and Drug Administration (FDA) Office of Generic Drugs has reported improvements in the number of generic drugs approved in its 2023 Annual Report, and detailed deficiencies that applicants needed to resolve before an approval could be made.
Alongside this, the agency highlighted several actions that were made to fulfil its bid to improve generic medicine access.
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The recent report highlighted that the FDA approved 956 generic drugs and issued 1,493 complete response letters last year, an improvement on 2022’s 914 approvals and 1,775 complete response letters.
Significant approvals in 2023 included the approval of numerous first generics of Takeda Pharmaceuticals’ Vyvanse (lisdexamfetamine dimesylate), a treatment for attention deficit hyperactivity disorder (ADHD) in patients six years and older and for moderate to severe binge eating disorder (BED) in adults.
The agency also approved the first generic of Pfizer’s Xeljanz (tofacitinib citrate), an oral solution for the treatment of moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis amongst other conditions. As of 1 January 2024, Vyvanse has had a wholesale price of $1,292.61 per 100ct bottle of the 10mg oral capsules. According to GlobalData, the branded 200ml 1mg/ml oral solution for Xeljanz wholesales at $5,552.58.
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By GlobalDataIn recent years, the FDA has made larger efforts to encourage the development of generic medicines. In 2023, the organisation gave approximately $20m to fund science and research projects. It also expanded the responsibilities of the Generic Drug User Fee Act (GDUFA)-funded Center for Research on Complex Generics (CRCG) to improve research collaborations between the FDA, academic institutions, and the generic industry. In the same year, the FDA’s Office of Generic Drugs (OGD) also issued 12 policy documents to aid drug manufacturers in the development of generic drugs.
As of this year, the agency has continued with these developments, announcing its partnership with the European Medicines Agency (EMA) on 8 February. The two organisations have expanded the 2005 collaborative parallel scientific advice (PSA) programme, which gave sponsors a direct route to discuss scientific matters related to product development with regulators. The regulators extended the programme, allowing sponsors to continue engaging with regulators earlier in the development process.
In the 22 February report, OGD director Dr Lilun Murphy said: “OGD will continue to focus on matters such as operational modernisation, workforce excellence, communication through conferences and education, direct engagement with companies developing generic drugs, and the meeting of our overall GDUFA programme goals.”
