57 new drugs were approved in 2024
That is according to the FDA. Nature Reviews Drug Discovery summarizes the progress to date as follows.
The FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) approved 57 new therapeutic drugs (NTD) in 2024. This is slightly above the average of 53 NTDs per year for 2014–2024, and well below the all-time high of 71 approvals, in 2023.
There also has been a lot of progress on the biosimilar front as well. FDA’s 2024 report states:
CDER approved a record total of 18 biosimilars for 8 reference products in 2024, more than any previous year. We also surpassed our 60th biosimilar approval since 2015 when the first biosimilar was approved. In addition, this year 9 biosimilars, including those approved in 2024 and in previous years, were approved as interchangeable biosimilars, which means that they may be substituted for their reference product at the pharmacy without the intervention of the prescriber, subject to state law, similar to how generic drugs are substituted for brand name drugs.
One challenge for pharmaceutical firms is that although the number of therapeutics approved by the FDA in 2024 was higher than average, their sales projections are lower.
