The FDA's drug center approved 52 original biologics in 2025, more than twice its 2015 to 2022 pace
Published 2026-11-07 · By Pushbuild · Data: FDA Approvals Feed – Press Releases & New Drug Approvals
FDA's Center for Drug Evaluation and Research approved 52 original biologics license applications in 2025, up from 25 in 2022 and 19 in 2015. New-molecule drug applications held steady over the same years: 34 in 2025, against a range of 21 to 40 since 2017.
“The data file is updated each morning, Monday through Friday.”
— FDA, Drugs@FDA Data Files
| Year | New molecular entity NDAs | Original BLAs (incl. biosimilars) | Total |
|---|---|---|---|
| 2015 | 28 | 19 | 47 |
| 2016 | 12 | 15 | 27 |
| 2017 | 32 | 24 | 56 |
| 2018 | 38 | 24 | 62 |
| 2019 | 37 | 23 | 60 |
| 2020 | 40 | 22 | 62 |
| 2021 | 32 | 21 | 53 |
| 2022 | 21 | 25 | 46 |
| 2023 | 36 | 29 | 65 |
| 2024 | 33 | 44 | 77 |
| 2025 | 34 | 52 | 86 |
| 2026 (to Oct 27) | 34 | 29 | 63 |
Biologics passed new chemical drugs in 2022 and have stayed ahead every year since; 2026 has 63 approvals through October 27.
Caveats
From Drugs@FDA, which covers the Center for Drug Evaluation and Research; vaccines, blood products and gene therapies licensed by the Center for Biologics Evaluation and Research are not included. Original BLAs include biosimilars, so the count is not the same as FDA's "novel drug approvals" list. NDAs counted are original applications with submission class "new molecular entity".
Sources
- FDA, Drugs@FDA Data Files, read through the Pushbuild FDA Approvals Feed – Press Releases & New Drug Approvals API on 2026-11-07
Data as of 2026-11-07. Every figure in this post is in the table above and the CSV below.
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