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FDA’s 2022 Drug Approvals


2022 was a good year, but not a great year for innovation. According to the FDA’s Center for Drug Evaluation and Research’s (CDER) New Drug Therapy Approvals 2022 report, there were 37 novel drugs approved in 2022. This number is lower than the historical rate of approbations between 2013-2021 (43.4 new drugs per year) and even lower relative to the past 5 years (51.2 apps per year).

However, 54% (20 out of 37) of the drugs were approved for their first class. We are also entering the era of precision medicine. 54% (20 out 37) were for rare and orphan diseases. Of the 37 approved drugs, 32% (n=12), were approved through the Fast Track Status; 35%(n=13), were approved with Breakthrough Therapy designations; 57% (11) were approved based upon Priority Review Designations and 16% (n=6) under the Accelerated Approval Program. Short summary: 65% (n=24%) of the 37 drugs approved were subject to an expedited review.

Sixty-eight percent (n=25), of the 37 drugs approved, were approved first in the USA before any other country.

In addition, seven biosimilars were approved by FDA in 2022 for products such as Avastin (n=2) Humira and Lucentis, Neulasta, Neupogen (n=2) and Lucentis (n=2). The…

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