FDA announces website for complex generics

Regulatory NewsRegulatory News | 05 August 2022 |  By 

The US Food and Drug Administration (FDA) just launched a new webpage to share recent actions and activities related to complex generic drugs to spur their development.
“Since these products are generally harder to develop, fewer exist, resulting in less market competition. This means that complex generics may be more expensive and less accessible to the patients who need them,” said the FDA announcement. “Complex generics are a key component of FDA’s Drug Competition Action Plan, which aims to bring more drug competition to the market and address the high cost of medicines, and the Generic Drug User Fee Amendments, which include specific provisions related to complex generics.”
FDA approves dozens of complex generics every year, according to the announcement. Some approvals this year include the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) inhalation aerosol to treat asthma and chronic obstructive pulmonary disease (COPD); the first generic of Apokyn (apomorphoine hydrochloride injection) to treat hyopomobility “off” associated with advanced Parkinson’s disease; and the first generic of Restastis (cyclosporine ophthalmic emulsion) 0.05% single-use eye drops to increase tear production in patients experiencing ocular inflammation.
The agency plans to hold a workshop on 20-21 September on advancing complex generic drug development and ways to translate science to approvals.
FDA’s Office of Generic Drugs (OGD) announced in 2020 that it would focus on complex generic drug development because these products are “harder to ‘genericize’ and often have less market competition” than other types of generics (RELATED: FDA kicks off GDUFA III reauthorization process, Regulatory Focus, 21 July 2020).
Last year, FDA heard from industry at a public workshop on ways to accelerate complex generic drug development; industry members presented new approaches for assessing bioequivalence, and using a non-US based reference listed drug (RLD) for approving drugs in the US (RELATED: FDA’s OGD hears ways to accelerated complex generic development, Regulatory Focus, 24 June 2021).


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Tags: complex, FDA, generics

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