FDA sees room for growth for complex generics

The complex generic market needs to “achieve parity” with the innovator market, as the number of approvals is lagging the innovator sector and has not achieved its full market potential, said Robert Lionberger, director of the US Food and Drug Administration’s (FDA) Office of Research and Standards in the Office of Generic Drugs (OGD).

Lionberger made the remarks at the Association for Accessible Medicines’ (AAM) GRx+Biosim conference in Bethesda, MD last week.

While 25% of all approved reference listed drugs (RLDs) are deemed complex products, only 13% of all generic drugs approvals in FY 2022 had this distinction. A product is considered complex if it 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, such as a transdermal patch, a metered dose inhaler or an extended release injectable.

To achieve parity with the brand name sector, complex generic approvals should be double what they are now, Lionberger said. “There is room for growth for complex [generic] products…..We have to get this number up to 25 percent of submissions.”

His remarks follow a recent pledge by FDA Commissioner Robert Califf to boost complex generic drug development. (RELATED: Califf: FDA committed to boosting complex generic drug development, Regulatory Focus 20 September 2022)

Despite FDA’s entreaties to push complex generic development, the percentage of complex generics compared to the total ANDA submission pool has stayed relatively flat. In FY 2022, the percentage was 16%, in FY 2021 it was 17% and in FY 2020 it was 15%.

In other areas, Lionberger noted that FDA exceeded its Generic Drug User Fee Amendment (GDUFA II) goals related to pre-ANDA meetings, due to an increasing number of sponsors requesting pre-ANDA meetings. There were 103 meetings in FY 2020, 124 in 2021 and 134 in 2022. These meetings help facilitate the adoption of innovative bioequivalence (BE) techniques in complex generic drug development.

Sponsors should request pre-submission meetings before conducting new or unique studies for complex generics. These studies should follow product development meetings.

In responding to a question on how to make the most out of pre-ANDA meetings, Lionberger said sponsors should ask specific questions and avoid general questions. “Do not ask if your drug meets specifications, frame it better for [these] meetings.”

In other areas, Lionberger said sponsors should request a teleconference if a revised product-specific guidance (PSG) contradicts the information in a former PSG that impacts the development of a product.

“It is not the intention of the PSG to interrupt your process development.” He added that the agency may not be aware of this disconnect until the product is under review.

Lionberger also noted that the top GDUFA III research priorities for FY 2023 are to develop methods for generics to address nitrosamine risks; and to enhance the efficiency of bioequivalence approaches for complex active ingredients, complex dosage forms and formulations, and complex routes of delivery. The agency previously announced these priorities on 25 October.

AAM meeting

FDA sees room for growth for complex generics

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