How many monoclonal antibodies are FDA approved?
Published totals, a dated FDA Purple Book count, and why they differ
Matic Broz, PhD8 min
The FDA had licensed 159 monoclonal antibody products by September 25, 2026, by our count of the agency's Purple Book, and 150 of them still hold an active license. The most cited published total is 169 FDA-approved antibody-based biologics through the end of 2025, a broader count that also includes Fc fusion proteins.
The two figures agree once their definitions are aligned. Both are dated counts: the published total stops at December 2025, ours at the Purple Book's September 2026 release.
How many monoclonal antibodies are FDA approved?
The FDA had approved 169 monoclonal antibodies and antibody-based biologics by December 31, 2025, according to the latest annual review by William Strohl.[1]
This is the broad therapeutic-antibody count used in the peer-reviewed literature. 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 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 antibody products does the FDA Purple Book list?
The Purple Book, the FDA's database of every licensed biological product, listed 159 antibody products in its September 2026 release, and 150 of them were still licensed.[2] We counted each antibody once, at its first license, and kept formats, Fc fusion proteins and biosimilars apart rather than folding them into one total. The nine revoked products include the first therapeutic antibody, muromonab-CD3, and the immunotoxin moxetumomab pasudotox. Another 67 biosimilar licenses copy 14 of the counted antibodies.
| Format | Licensed by September 2026 | Still licensed | Through 2025 | Strohl, through 2025 |
|---|---|---|---|---|
| Unconjugated antibodies | 116 | 112 | 113 | 113 |
| Antibody-drug conjugates | 15 | 15 | 14 | 14 |
| Bispecific antibodies | 14 | 14 | 14 | 15 |
| Antibody fragments | 6 | 5 | 6 | 6 |
| Antibody mixtures | 2 | 2 | 2 | 2 |
| Radioconjugates for therapy | 2 | 1 | 2 | 2 |
| Radioconjugates for imaging | 3 | 1 | 3 | Not counted |
| Immunotoxin | 1 | 0 | 1 | 1 |
| All antibody products | 159 | 150 | 155 | 153 |
| Fc fusion and Fc-based proteins | 21 | 20 | 18 | 16 |
| Biosimilar licenses | 67 | 67 | 62 | Not counted |
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.[3] 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.[3] The difference is scope: 15 across therapeutic areas, 13 in cancer immunotherapy.
Our Purple Book count gives 14. The difference is tebentafusp (Kimmtrak), a T-cell receptor fused to an anti-CD3 antibody fragment, which Strohl counts as a bispecific but whose name carries no antibody stem.[6][2]
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.
Our Purple Book count shows how far definitions alone move the number. Removing Strohl's 16 Fc fusions from 169 leaves 153 antibodies. Our rule then drops tebentafusp and adds three diagnostic imaging antibodies that Strohl's therapeutic count excludes, giving 155, exactly our total through 2025. The counts match in every other format in Table 1. Our Fc fusion count through 2025 is 18 rather than 16, a gap we cannot itemize because Strohl's product list is unpublished.[1][2]
This is the same counting problem seen across FDA-approved drugs: products, active ingredients, applications, and molecular formats are not interchangeable units. The Purple Book alone lists 185 antibody licenses for its 159 antibody products, because subcutaneous versions, combinations and relicensures receive licenses of their own.
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][7]
The pace accelerated sharply in the past decade. In the Purple Book, 37 antibody products had been licensed by the end of 2013, and 118 more followed from 2014 through 2025. That is an average of 9.8 a year, against 2.0 a year from 1997 through 2013.[2] Strohl's broader count, which includes Fc fusions, gives 125 approvals over the same 12 years, or 10.4 a year.[1]
Strohl counted 15 antibody-based biologics in 2024 and 10 in 2025.[1][6] The Purple Book gives 13 and 10 antibody products; the 2024 difference is two Fc-based proteins, sotatercept and nogapendekin alfa inbakicept, and the ten 2025 antibodies are the same ten in both. By September 25, 2026, four more antibodies had been licensed: the antibody-drug conjugate pivekimab sunirine and the antibodies veligrotug, garetosmab and apitegromab.[2] Veligrotug is the first licensed antibody named with -tug, one of four stems the World Health Organization introduced in 2022 for new antibody names.[8] Like every antibody name chosen since 2017, it no longer says whether the antibody is human, humanized or chimeric; its label says humanized.
Methodology
We counted antibody products in the FDA Purple Book database download for September 2026, the file purplebook-search-September-data-download.csv, dated September 30, 2026 and downloaded on October 23, 2026.[2] Its most recent approval is dated September 25, 2026. The Purple Book lists every licensed biological product, including revoked licenses, with one row per strength and presentation.
We included original biologics license applications under section 351(a) of the Public Health Service Act whose proper name contains an antibody name stem. That means -mab, or one of the four stems introduced in 2022 for new antibody names: -tug, -bart, -ment and -mig.[8] Muromonab-CD3, named before the -mab stem existed, was added by hand. Biosimilars, licensed under section 351(k), were counted as licenses in their own row.
Each antibody counts once, dated by its earliest license. Another 26 antibody licenses cover new routes and formulations, subcutaneous co-formulations with hyaluronidase, fixed combinations of antibodies already licensed and one relicensure, and were not counted again. Two products that introduced new antibodies together count as one mixture each: the three-antibody Ebola treatment Inmazeb, and Opdualag, which pairs nivolumab with the new antibody relatlimab.
Each product received one format from its labeled structure. Fc fusion and Fc-based proteins, polyclonal antibody fragments such as the antivenom CroFab, and tebentafusp were recorded but left out of the antibody count. A product counts as licensed when any of its licenses is active and as revoked only when all of them are.
Purple Book dates are database license dates, which differ from first approval for at least two legacy products. Muromonab-CD3 appears in 1992 rather than 1986, and gemtuzumab ozogamicin, first approved in 2000 and withdrawn in 2010, appears only at its 2017 relicensure. A license is also not proof of sale: the imaging antibody capromab pendetide is still licensed but has no marketed presentation. Emergency use authorizations, such as those for COVID-19 antibodies, are not licenses and do not appear.
Format calls involve judgment, so the per-product classification, summary and analysis script record every license number, date, status and category.
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
