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How many monoclonal antibodies are FDA approved?
The FDA had approved 169 antibody-based biologics by the end of 2025. The total includes 113 IgG-based antibodies, 15 bispecifics, 14 antibody-drug conjugates, and other antibody formats.
Matic Broz Computational chemist
The latest complete count is 169 FDA-approved monoclonal antibodies and antibody-based biologics through the end of 2025. Of these, 113 are IgG-based antibodies and 15 are bispecific antibodies.
The cutoff matters. The FDA's 2026 list already includes further antibody products, but no equivalent full-category audit has yet replaced the 2025 total. The 169 figure is a dated baseline, not a live inventory.
How many monoclonal antibodies are FDA approved?
The FDA had approved 169 monoclonal antibodies and antibody-based biologics by December 31, 2025.[1]
This is the broad therapeutic-antibody count used in the latest peer-reviewed structural review. It includes conventional IgG antibodies as well as Fc fusion proteins, bispecific antibodies, antibody-drug conjugates, fragments, mixtures, and radioimmunoconjugates.
Within the total, 113 products are IgG-based antibodies. That is the closest published answer for readers who mean conventional full-length monoclonal antibodies rather than the wider family of antibody-derived medicines.[1]
The eight categories add to 169. IgG-based antibodies account for two-thirds of the total, while engineered formats make up the remaining third.[1]
The count describes therapeutic products, not the number of possible antibody sequences or antibody classes. It also does not count every investigational molecule produced by modern antibody design.
How many bispecific antibodies are FDA approved?
The FDA had approved 15 bispecific antibodies by the end of 2025, including 10 T-cell engagers.[1]
Blinatumomab became the first FDA-approved bispecific antibody in 2014.[7] The total reached 15 when the FDA approved linvoseltamab, sold as Lynozyfic, for relapsed or refractory multiple myeloma on July 2, 2025.[4]
Some narrower sources report 13 because they count bispecific cancer immunotherapies rather than every FDA-approved bispecific product.[5] The 15-product total also includes emicizumab for hemophilia and faricimab for retinal disease.[7] The difference is scope: 15 across therapeutic areas, 13 in cancer immunotherapy.
Why do published antibody counts disagree?
Published totals disagree because “monoclonal antibody” can mean a conventional IgG molecule, any antibody-based therapeutic format, an approved product, an active product, or every product ever approved.
The latest structural audit counts 113 IgG-based antibodies but 169 antibody-based biologics in total.[1] A source that includes biosimilars, new formulations, withdrawn products, emergency-use authorizations, or approvals outside the United States can produce a higher number. A source limited to marketed conventional IgGs will produce a lower one.
The 169 total excludes four COVID-19 antibody products or mixtures that received emergency use authorization but not full FDA approval.[1] It also counts antibody-drug conjugates and Fc fusions that a strict list of conventional monoclonal antibodies may omit.
This is the same counting problem seen across FDA-approved drugs: products, active ingredients, applications, and molecular formats are not interchangeable units.
How quickly has the number of FDA-approved antibodies grown?
The FDA approved its first monoclonal antibody in 1986, its 100th in 2021, and its 169th antibody-based biologic by the end of 2025.[1][3]
The milestone totals come from the 2021 announcement and the annual reviews of 2024 and 2025 approvals.[1][2][3]
The pace accelerated sharply in the past decade. The FDA approved 125 antibody-based drugs from 2014 through 2025, which is 74% of the cumulative 169-product total. That period averaged 10.4 approvals per year, compared with 2.35 per year from 1997 through 2013.[1]
Fifteen antibody-based biologics were approved in 2024 and another 10 in 2025.[1][2] The FDA's 2026 novel-drug list already contains further antibody products, so the 169 figure remains a December 2025 baseline.[6]
ProteinIQ. "How many monoclonal antibodies are FDA approved?" Published July 30, 2026. Accessed [your access date]. https://proteiniq.io/guides/how-many-monoclonal-antibodies-are-fda-approved
Sources▼
- Structure and function of therapeutic antibodies approved by the US FDA in 2025 Antibody Therapeutics · 2026. https://academic.oup.com/abt/advance-article/doi/10.1093/abt/tbag027/8697373
- Structure and function of therapeutic antibodies approved by the US FDA in 2024 Antibody Therapeutics · 2025. https://academic.oup.com/abt/article/8/3/197/8176596
- FDA approves 100th monoclonal antibody product Nature Reviews Drug Discovery · 2021. https://www.nature.com/articles/d41573-021-00079-7
- Drug Trials Snapshot: LYNOZYFIC U.S. Food and Drug Administration · July 30, 2026. https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshot-lynozyfic
- 2026 Cancer Immunotherapy Insights + Impact Report Cancer Research Institute · 2026. https://www.cancerresearch.org/cancer-immunotherapy-report-2026
- Novel Drug Approvals for 2026 U.S. Food and Drug Administration · July 30, 2026. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026
- Mechanism of Action and Pharmacokinetics of Approved Bispecific Antibodies Biomolecules & Therapeutics · 2024. https://pmc.ncbi.nlm.nih.gov/articles/PMC11535297/
Founder and computational chemist, ProteinIQ
Dr. Matic Broz is the founder of ProteinIQ and a computational chemist. He completed a PhD focused on protein structure, molecular dynamics, and neural networks, and writes about structural biology and scientific software.