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Another Record Year for Generic Drug Approvals but Questions on Competition Remain

Posted 16 October 2019 | By Zachary Brennan 

Another Record Year for Generic Drug Approvals but Questions on Competition Remain

For each of the last five years, the US Food and Drug Administration (FDA) has set generic drug approval records, but questions have lingered on whether these high approval numbers are translating into competition.

FY 2019 figures show a total of 1,171 generic drug approvals (935 full approvals and 236 tentative approvals), which breaks FDA’s previous all-time record of 971 full and tentative approvals for FY 2018. And although the abbreviated new drug application (ANDA) approval record was technically broken in August of this year, FDA is approving increasing numbers of complex generics, which can be more difficult to copy and traditionally lack competition.

Since 2017, FDA has stepped up its efforts to promote generic drug competition by offering priority reviews for certain ANDAs, a new competitive generic therapy (CGT) designation and by providing a list of drugs that lack generic competition.

And although first generic approval numbers have been on par with recent previous years, a report from Pew Research earlier this year found that the increase in approved generic drugs from 2013 to 2017 was largely driven by approvals of fourth, fifth, sixth and even later versions of generics. And costs generally decline most significantly once second and third generics enter the market.

Robert Pollock, senior advisor to Lachman Consultants, previously explained to Focus that it can be difficult to assess how the approvals translate into competition because it can take up to five years for approved generic drugs to launch.

Similarly, a study published in JAMA Network Open last week noted that while the number of ANDAs approved from July 2016 to December 2018 trended upward, the number of generics approved with limited competition or that had experienced a recent shortage remained flat.

As for FDA’s priority ANDA and CGT programs, according to FDA’s most recent quarterly report for both programs, the numbers awaiting FDA action have swelled, with more approvals likely as the goal dates for those applications approach.

FDA Acting Commissioner Ned Sharpless also noted recent issues related to the quality of generics and said there will be additional new guidance and policies to help generic drug applicants, “including planning additional conferences on generic drug development to further engage with stakeholders and generic drug developers.”


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