This is according to the FDA. Nature Reviews Drug Discovery The following is a summary of the progress to date.
The FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) approved 57 new therapeutic drugs (NTDs) 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.
Considerable progress has also been made on the biosimilar front. The FDA’s 2024 report states:
CDER approves a record total of 18 biosimilars for 8 reference products in 2024, an increase from the previous year. We have also surpassed our 60th biosimilar approval since 2015 when the first biosimilar was approved. In addition, 9 biosimilars, including those approved this year and in previous years, were approved as interchangeable biosimilars, meaning they can be substituted for their reference product at the pharmacy without prescriber intervention, subject to state law. May go. Just like generic drugs are replaced by brand name drugs.
One challenge for pharmaceutical companies is that although the number of therapeutic drugs approved by the FDA in 2024 was higher than average, their sales are projected to be low.
