FDA updates guidance on generic approvals to increase competition

By Vassia Barba

- Last updated on GMT

(Image: Getty/maxsattana)
(Image: Getty/maxsattana)

Related tags Generic drug Generic drugs Generics Food and drug administration Fda competition

Aiming to encourage entry of generic drugs on the market, the US FDA published a finalized guidance that regulates processes for relevant designations and expedited approvals.

The updated recommendations​ published by the US Food and Drug Administration (FDA) regard the competitive generic therapy (CGT) designation, which is intended to provide incentives for the development of generic versions of drug products that currently face ‘little or no competition’, according to the agency.

Incentives for developers and manufacturers of such drugs include expedited review and approval of an abbreviated new drug application (ANDA) by the FDA. Since the establishment of the CGT designation in 2017, the agency has received more than 350 requests for this designation, and has approved 31 products, which are listed publicly​.

In a statement, FDA commissioner Stephen Hahn commented that the CGT designation “has been a significant advancement in helping to bolster generic drug competition in the US.”

Recommendations on the CGT designation were finalized after the agency reviewed comments received on the draft guidance published in February. The final guidance describes the process that applicants should follow to request CGT designation, as well as the required criteria.

Moreover, the guidance provides information about the actions the agency may take to expedite approvals, such as meetings with FDA teams regarding the development of the product or the submission of the ANDA.

The guidance also includes information about a 180-day ‘exclusivity period’, which blocks the approval of a drug that is the same as a CGT-designated one. The exclusivity period, according to the FDA, is intended to incentivize competition for drugs that are not protected by a patent.

Recent analysis published by the regulatory agency showed that generic drug prices declined as competition increased​, examining products that entered the US market between 2015 and 2017.

According to the analysis, prices dropped by 39% once a generic competitor entered the market, and by 54% after two competitors claimed a share on the market.

At the end of 2019, the FDA marked a record year​ on the approval of generic drugs, with the number of products receiving the green light to enter the market reaching 1,171. Out of these, 125 were the first generics of their respective branded product to be approved.

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