FDA hits new record for generic drug approvals

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Alexander Gaffney Senior Manager, Health Research Institute, PwC US October 19, 2018

More generic drugs were approved during the 2018 fiscal year than in any time in US history, according to new datafrom the FDA. The FDA approved 781 generics in fiscal year 2018, up from a then-record-setting 763 in fiscal year 2017. Regulators also tentatively approved 190 generics, double the 95 the agency approved in fiscal year 2017.

The new record comes amid regulatory changes meant to expedite approvals and enhance the review process. For example, the FDA has established a priority review pathway for generic drugs, a new market exclusivity provision for “competitive” generic drugs, $493 million in user fees with which to hire additional review staff, new guidance documents to facilitate development and 700 additional staff in the FDA’s Office of Generic Drugs compared to 2014.

The agency is continuing to roll out additional guidance that could help continue its record-setting approval streak. For example, the FDA released two additional guidance documents last week detailing how developers of “complex” generic drugs—products with complex formulations or active ingredients—can more easily obtain approval for products involving adhesive transdermal and topical delivery systems.

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HRI impact analysis

The FDA’s approval of new generic drugs can save consumers money, but these approvals will not have a dramatic impact on the overall drug spend. The entry of a single generic drug typically lowers the price of a drug by less than 10 percent, according to FDA data. Only the entry of a second generic decreases the price of the drug to around 50 percent of the original.

The FDA’s approval of additional generics also does nothing to affect any drug approved through the biologics pathway. Those drugs require biosimilar competition, and the FDA had approved just 11 as of June 2018, with just three of those drugs actively marketed.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Alexander Gaffney

Senior Manager, Health Research Institute, PwC US

Tel: +1 (202) 836 1604

Jason Ranville

Senior Manager, Health Research Institute, PwC US

Noah Marwil

Research Analyst—Health Research Institute, PwC US

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