Biosimilar biological product approvals

RecordSTO-GJ0HSPRESA-Y30Y07N4XM-BZF857

18

United States · 2024

Biosimilar biological product approvals in the United States were 18 in 2024 (FDA).

Original source

New drug approvals in United States: every year, the rank and how it is measured

Publisher
FDA
Authority tier
T1 Official
Locator
A Record Year for Biosimilar Approvals
Retrieved
17 Sep 2026
Status
Verified

What the source says

This milestone is due to CDER approving in 2024 a record total of 18 biosimilars for 8 reference products, more than any previous year.

Checked: the figure 18is stated in this passage. If it does not match, the extraction is wrong and we want to know.

Cite this figure

APA

U.S. Food and Drug Administration. (2024). CDER Brings Many Safe and Effective Therapies to Patients and Consumers in 2024. Retrieved September 17, 2026, from https://www.fda.gov/news-events/fda-voices/cder-brings-many-safe-and-effective-therapies-patients-and-consumers-2024. Via StatOrigin, https://statorigin.org/stat/stat_GJ0HSPRESAY30Y07N4XMBZF857

Other formats: MLA, Chicago, BibTeX
MLA
U.S. Food and Drug Administration. "CDER Brings Many Safe and Effective Therapies to Patients and Consumers in 2024." 2024, https://www.fda.gov/news-events/fda-voices/cder-brings-many-safe-and-effective-therapies-patients-and-consumers-2024. Accessed 17 Sept. 2026 via StatOrigin, https://statorigin.org/stat/stat_GJ0HSPRESAY30Y07N4XMBZF857.
Chicago
U.S. Food and Drug Administration. "CDER Brings Many Safe and Effective Therapies to Patients and Consumers in 2024." 2024. https://www.fda.gov/news-events/fda-voices/cder-brings-many-safe-and-effective-therapies-patients-and-consumers-2024. Accessed September 17, 2026. Cited from StatOrigin, https://statorigin.org/stat/stat_GJ0HSPRESAY30Y07N4XMBZF857.
BibTeX
@misc{fda2024biosimilarbzf857, author = {{U.S. Food and Drug Administration}}, title = {CDER Brings Many Safe and Effective Therapies to Patients and Consumers in 2024}, year = {2024}, howpublished = {StatOrigin, https://statorigin.org}, url = {https://statorigin.org/stat/stat_GJ0HSPRESAY30Y07N4XMBZF857}, note = {Original source: https://www.fda.gov/news-events/fda-voices/cder-brings-many-safe-and-effective-therapies-patients-and-consumers-2024. Accessed September 17, 2026.} }

Data published under CC BY 4.0. The citation credits the original publisher and links to this permanent record.

Provenance and verification

Everything needed to check this number yourself, without taking our word for it.

Chain of custody
Record: STO-GJ0HSPRESA-Y30Y07N4XM-BZF857 T1 Official

Primary source

Publisher
U.S. Food and Drug Administration · homepage ↗
Authority tier
Tier 1 · Multilateral Official
Report
CDER Brings Many Safe and Effective Therapies to Patients and Consumers in 2024
Type
Press release
Published
—
Locator
A Record Year for Biosimilar Approvals
Retrieved
17 September 2026
Link status
Reachable (HTTP 200)
Report licence
See source

Verification

Status
Verified
Review protocol
Editorial review
Checked on
17 September 2026
Last revision
17 September 2026
Permanent URL
/stat/stat_GJ0HSPRESAY30Y07N4XMBZF857