Califf: FDA committed to boosting complex generic drug development

Regulatory NewsRegulatory News | 20 September 2022 | By

FDA Commissioner Robert Califf

Robert Califf, commissioner of the US Food and Drug Administration (FDA), said the agency is looking at new ways to assess bioequivalence and increase its early interactions with industry to promote more first-cycle approvals of complex generics at a 20 September webinar sponsored by FDA’s Small Business and Industry Assistance (SBIA) program.
The workshop, entitled “Advancing Generic Drug Development: Translating Science to Approval” focused on common deficiencies in abbreviated new drug application (ANDA) submissions and examined various areas of research for these products. FDA announced the workshop over the summer, noting that complex generics are “harder to ‘genericize’ and often have less market competition” than other types of generic products. (RELATED: FDA announces website for complex generics, Regulatory focus 5 August 2022)
Califf said the purpose of the workshop was to promote more first-cycle approvals of these products, which serve an “important need” and provide “enormous benefits to patients and consumers.” A complex generic drug product is deemed complex because it either has a complex active ingredient, such as a peptide or polymeric compound; is a complex formulation; has a complex route of delivery; or has a complex dosage form.

Calif said the agency is taking several approaches to encourage the development of these products. One approach is developing alternative avenues for evaluating a drug’s bioequivalence that would eliminate unnecessary human studies.
The agency is also modernizing its policies to help industry maximize the use of the 505(j) pathway for ANDAs and intends to provide greater clarity in guidances on developing generic versions of drug-device combination products. In addition, Califf said that FDA is modernizing its policies to increase interaction with industry to ensure that submissions are complete.
As an example of a recent success story for a complex generic, Califf highlighted the approval of the first generic version of Allergan’s Restasis (cyclosporine ophthalmic emulsion) single-use eye drops for increasing tear production in patients experiencing dry eye syndrome. The generic approval followed ten years of GDUFA-funded research to develop bioequivalence recommendations for the drug.
“Thanks to that research we have an important and affordable generic that is available,” said Califf.
The agency is also developing other “enhancements” to its complex generics program through the third iteration of the Generic Drug User Fee Amendments (GDUFA III). Those enhancements include additional science meetings with industry, prior to and after submission, so sponsors can get timely input on their development programs and enable better quality ANDA submissions.
FDA meeting on complex generics


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