Biosimilar biological product approvals

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

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Published under CC BY 4.0. Attribute the original publisher; the citations below do that for you and link to this permanent record.

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

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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.

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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.

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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.} }

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Record last modified 17 September 2026. Value type: actual. Update cadence: annual. This page is permanently addressable at statorigin.org/stat/stat_GJ0HSPRESAY30Y07N4XMBZF857.