FDA 2022 Drug Approvals – Healthcare Economist





2022 was a good year, but perhaps not a great year for innovation. According to the Food and Drug Administration’s Center for New Drug Treatment Approvals Report (CDER) 2022, 37 new drugs were approved in 2022. This number is lower than the historical average for approvals between 2013-2021 (43.4 approvals per year) and significantly lower than in previous years. the past five years (51.2 approvals per year).

On the other hand, the majority of drugs (54%, 20 out of 37) were first in their class. The era of precision medicine is also upon us as 54% (20 out of 37) were for rare or orphan diseases. Of the 37 approvals, 32% (n = 12) were approved via Fast Track status; 35% (n = 13) approved the breakthrough treatment label; 57% (n = 21) were approved based on priority review designation and 16% (n = 6) were approved under the accelerated approval program. In summary, 65% (n = 24) of the 37 approved drugs received some type of urgent review.

Of the 37 approved drugs, 68% (n = 25) were approved for the first time in the United States before any other country.

In addition, in 2022 the FDA approved seven biosimilar products including Avastin (n = 2), Humira, Lucentis, Neulasta (n = 2), and Neupogen. The cumulative biosimilars approved by the FDA to date are shown in the figure below.

You can find the full list of product approvals in the FDA report here.



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