Drugs

Two FDA Guidances on Advancing Complex Drug Generics

FDA has released two guidances as part of its initiative to make it easier to introduce generic copies of complex drugs. The first is a draft guidance on “Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA” that is intended to give advice on meeting requests for product development meetings, pre-submission meetings, and mid-review cycle meetings. The meetings can improve development timelines and are similar to those requested under the new drugs program.

The second is a draft guidance on “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin” that is intended to help applicants determine when submission of ANDAs for complex peptides would be appropriate. The document specifically addresses glucagon, liraglutide, nesiritide, teriparatide, and teduglutide ANDAs that reference brand-name versions of these peptides manufactured using recombinant DNA technology. “The recommendations in the new guidance will help ensure that the risk of an immune response from the generic due to differences in impurities will not differ from that of the reference drug,” an agency notice says.

FDA says it will soon release other important policies to help bring to market generic copies of complex drugs. “But we know that better guidance isn’t the only answer,” FDA commissioner Scott Gottlieb says in the notice. “Some drugs lack generic competition because they cannot be measured through traditional in vivo bioequivalence methods and there’s no efficient and convincing bioequivalence test method available. In these instances, an applicant needs to conduct more extensive clinical endpoint testing to show bioequivalence of a generic drug to a brand-name drug. This can be burdensome and discourage generic product development. A further barrier to generic competition for certain complex drug products is the lack of established methods for showing the sameness of the active ingredient of a proposed generic drug to a brand-name drug for certain complex drugs.”

Additionally, Gottlieb says that going forward the agency’s generic drug regulatory science program “will work to identify gaps in the science and develop more tools, methods, and efficient alternatives to clinical endpoint testing, where feasible. Planned workshops will also help develop new analytical tools,” he adds.

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