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Generics approvals remain high in US in 2019

Generics/General | Posted 10/04/2020 0 Post your comment

In February 2020, the US Food and Drug Administration’s (FDA) Office of Generic Drugs released their 2019 Annual report which highlighted the year’s key achievements. The report stated that in 2019, the Office of Generic Drugs (OGD) facilitated 1,014 generic drug final and tentative approvals. This is slightly lower than the 1,021 approvals of 2018 but remains high enough to make a positive contribution to the FDA’s generic drug programme.

The report also outlined that in the US, 90% of prescriptions dispensed are now for FDA-approved generic drugs. FDA advocates market entry and use of generic drug products as they can offer more affordable access to medicines through generics competition which can lead to reduced product prices. FDA and its generic drug programme strive to ensure that safe, effective, high quality and more affordable generic drugs continue to play a large role in their healthcare system now and in the future.

Regarding the number of generics approved, Dr Sally Choe, Director, Office of Generic Drugs, Center for Drug Evaluation and Research, noted that ‘Of these approvals, 110 were for complex generic drugs, which are harder to develop and traditionally have lacked competition in the marketplace. The approvals contain 108 first generics – medicines that had no generics competition – including drugs to treat or prevent serious conditions such as pulmonary arterial hypertension, breast cancer, seizures, stroke, depression and various infections’. The first generics mentioned include generics of highly grossing products such as Pfizer's Lyrica, Bristol-Myers Squibb's Eliquis and GlaxoSmithKline's Advair.

Dr Choe noted that in 2019 the FDA’s generic drug programme was a success in terms of the numbers of approvals. Overall, this means it has provided more treatment choices for patients and greater access to affordable products for a wide range of medical conditions. In conclusion, the report noted that in 2020, public health will remain of paramount importance for FDA. They have published a product-specific guidance which aims to facilitate future generic drug development. FDA strives to keep the number of generics approvals high, whilst maintaining safety and efficacy of products. This should ensure access to high quality affordable medicines for all US citizens.

Improving the pathway for generics approval in the US: 2019 update

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