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FDA’s 2022 Drug Approvals – Healthcare Economist


2022 is a good year, but maybe not a great year for innovation. According to FDA’s Center for Drug Evaluation and Research (CDER) 2022 New Drug Treatment Approval Report, 37 new drugs will be approved in 2022. This figure is lower than the historical approval rate for 2013-2021 (43.4 approvals per year), especially compared to the past 5 years (51.2 approvals per year).

On the other hand, the majority of drugs (54%, 20 of 37) were first-in-class. The era of precision medicine is also on the horizon, as 54% (20 of 37) target rare or orphan diseases. Of the 37 approvals, 32% (n=12) received Fast Track approval; 35% (n=13) received Breakthrough Therapy designation; 57% (n=21) received Priority Review designation, and 16% (n =6) Approved under the Accelerated Approval Program. Briefly, 65% (n=24) of the 37 drugs approved received some type of accelerated review.

Of the 37 drugs approved, 68% (n=25) were first approved in the US before being approved in any other country.

Additionally, in 2022, the FDA has approved seven biosimilars for use in products, including Avastin (n=2), Humira, Lucentis, Neulasta (n=2), and Neupogen. The cumulative FDA approvals of biosimilars to date are shown in the chart below.

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





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