As of August 2026, 15 bispecific antibodies have received FDA approval, from blinatumomab (Blincyto) in 2014 to linvoseltamab (Lynozyfic) in 2025. This article provides an annotated list of all FDA-approved bispecific antibodies, with analysis of their mechanisms, engineering formats, and clinical significance.
List of FDA-approved bispecific antibodies
| Brand name | Active ingredient | Year | Targets | Format | Indication |
|---|---|---|---|---|---|
| Blincyto® | blinatumomab1 | 2014 | CD19 × CD3 | Tandem scFv (BiTE®) | R/R B-cell precursor ALL |
| Hemlibra® | emicizumab2 | 2017 | FIXa × FX | Common light chain IgG (charge-engineered) | Hemophilia A |
| Rybrevant® | amivantamab3 | 2021 | EGFR × c-MET | DuoBody® (IgG1) | NSCLC with EGFR exon 20 insertion |
| Kimmtrak® | tebentafusp4 | 2022 | gp100 × CD3 | ImmTAC (scFv-TCR) | Unresectable or metastatic uveal melanoma |
| Vabysmo® | faricimab5 | 2022 | VEGF-A × Ang-2 | CrossMab (with knobs-into-holes) | nAMD, DME, RVO |
| Tecvayli® | teclistamab6 | 2022 | BCMA × CD3 | DuoBody® (IgG4) | R/R multiple myeloma |
| Lunsumio® | mosunetuzumab7 | 2022 | CD20 × CD3 | Knobs-into-holes (IgG-hetFc) | R/R follicular lymphoma |
| Epkinly® | epcoritamab8 | 2023 | CD20 × CD3 | DuoBody® (IgG4) | R/R DLBCL; R/R follicular lymphoma |
| Columvi® | glofitamab9 | 2023 | CD20 × CD3 | CrossMab, 2:1 format | R/R DLBCL |
| Talvey® | talquetamab10 | 2023 | GPRC5D × CD3 | DuoBody® (IgG4) | R/R multiple myeloma |
| Elrexfio® | elranatamab11 | 2023 | BCMA × CD3 | IgG-hetFc (1+1) | R/R multiple myeloma |
| Imdelltra® | tarlatamab12 | 2024 | DLL3 × CD3 | Tandem scFv-scFc (BiTE) | R/R small cell lung cancer |
| Ziihera® | zanidatamab13 | 2024 | HER2 × HER2 (biparatopic) | Biparatopic IgG | HER2-positive biliary tract cancer |
| Bizengri® | zenocutuzumab14 | 2024 | HER2 × HER3 | Common light chain IgG (Biclonics®) | NRG1 fusion-positive NSCLC and pancreatic cancer |
| Lynozyfic® | linvoseltamab15 | 2025 | BCMA × CD3 | IgG4-hetFc (1+1) | R/R multiple myeloma |
Beyond the approved drugs, see our overview of examples of bispecific antibody drugs across formats and targets.
What makes bispecific antibodies stand out?
BsAbs are unique due to their ability to bind two different antigens simultaneously. This structure allows them to perform functions that monoclonal antibodies are not able to, such as bringing two different cell types into close proximity to facilitate an immune response. For instance, a bsAb can guide a T-cell to a cancer cell, enabling the T-cell to attack the cancer cell more directly. This dual-targeting is what sets them apart from conventional antibodies; we cover this in how bispecific antibodies differ from monoclonal antibodies.
Thus, the advantages of bispecific antibodies are substantial. BsAbs can target multiple pathways in a disease process, making them extremely versatile and effective. They can also reduce the number of medications a patient needs to take, simplifying treatment regimens.
Additionally, by engaging multiple targets, bsAbs can help overcome resistance mechanisms that often limit the effectiveness of single-target therapies. This makes them particularly valuable in treating complex diseases such as cancer.
Below, we group the approved bispecifics by mechanism and therapeutic area, and analyse how their engineering formats shape their clinical use.
The approved bispecifics by mechanism and therapeutic area
The 15 approved bispecific antibodies fall into a few clear groups defined by how their two arms work together. Read alongside the table above, these groups show why certain formats dominate certain indications.
T-cell engagers in hematologic cancers
The largest group redirects T cells against blood cancers by binding CD3 on one arm and a tumor antigen on the other. In lymphoma and leukemia, blinatumomab (Blincyto) pairs CD19 with CD3 for B-cell precursor ALL and was the first of the class. Mosunetuzumab (Lunsumio), epcoritamab (Epkinly), and glofitamab (Columvi) all engage CD20 in follicular lymphoma and diffuse large B-cell lymphoma.
Glofitamab stands out with its 2:1 architecture, using two CD20-binding arms and one CD3 arm to raise avidity for the tumor. In multiple myeloma, teclistamab (Tecvayli), elranatamab (Elrexfio), and linvoseltamab (Lynozyfic) target BCMA, while talquetamab (Talvey) addresses the newer target GPRC5D. Despite the shared CD3-engagement principle, the formats range from DuoBody and IgG-hetFc designs to tandem scFv, which has direct consequences for half-life and dosing schedules.
T-cell engagers in solid tumors
Redirecting T cells against solid tumors is harder, and only two approvals address it so far. Tebentafusp (Kimmtrak) uses an ImmTAC design, an affinity-enhanced TCR fused to an anti-CD3 scFv, to recognise a gp100 peptide presented on HLA-A*02:01 in uveal melanoma.
Tarlatamab (Imdelltra) is a BiTE that pairs DLL3 with CD3 in small cell lung cancer. The scarcity of solid-tumor approvals reflects the difficulty of finding tumor-selective targets and overcoming a suppressive tumor microenvironment.
HER2-directed bispecifics
The two most recent HER2 approvals show how differently the same antigen can be used.
Expert insight from evitria’s scientific team: biparatopic vs heterobispecific HER2 targeting
Two of the most recently approved bispecifics both involve HER2, but with fundamentally different strategies. Zanidatamab (Ziihera) is biparatopic: both arms bind HER2 at different epitopes (ECD2 and ECD4), causing receptor clustering, enhanced internalization, and disruption of HER2 signaling. Zenocutuzumab (Bizengri) uses HER2 merely as an anchor on the cell surface, while its second arm blocks NRG1-driven HER3 activation.
This illustrates a key principle in bispecific design: the same surface antigen can serve completely different roles depending on the engineering strategy. HER2 is a functional target for zanidatamab but a proximity anchor for zenocutuzumab. For researchers considering bispecific approaches, target selection is not just about what to bind, but what role each arm serves in the mechanism of action.
Julia Pizzolato, PhD
Receptor-modulating bispecifics
Not every bispecific recruits immune cells. Amivantamab (Rybrevant) binds EGFR and c-MET on the same tumor cell, promoting receptor degradation through Fc-dependent mechanisms and blocking ligand-driven signaling. It is used in NSCLC with EGFR exon 20 insertion mutations.
Non-immune, cofactor-mimetic bispecifics
Emicizumab (Hemlibra) is the outlier of the group. Rather than engaging immune cells or blocking a target, it bridges activated Factor IX and Factor X into the correct orientation to restore the function normally provided by Factor VIII in hemophilia A. It is the clearest example that a bispecific can act as a molecular tool, not only as a targeting agent.
Ophthalmology and anti-angiogenic bispecifics
Faricimab (Vabysmo) inhibits two drivers of vascular leakage at once, VEGF-A and Ang-2, using a CrossMab design. It is approved for neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion, and it shows how dual inhibition can extend dosing intervals in chronic eye disease.
Trends, observations, and outlook
A look across the timeline shows how quickly this field has matured.
Expert insight from evitria’s scientific team: the acceleration of bispecific approvals
The first bispecific antibody approval, blinatumomab, came in 2014. It took until 2017 for the second, emicizumab. By 2022, four more were approved in a single year, and 2023 and 2024 added seven more, with linvoseltamab bringing the total to 15 in 2025. This acceleration reflects three converging factors: the maturation of heterodimerization and chain-pairing engineering, growing clinical evidence validating the T-cell engagement mechanism, and platform technologies such as DuoBody, CrossMab, and BiTE that enable faster molecular development.
For researchers entering the bispecific space today, the engineering toolkit is substantially more mature than even five years ago. The challenge is no longer whether you can build a bispecific. It is whether you can produce it reliably, characterize it rigorously, and differentiate it clinically. This is where early-stage production quality and analytical rigor become the determining factors.
Julia Pizzolato, PhD
Momentum has continued into 2026, though recent activity has focused on broader indications and combination regimens for already-approved bispecifics rather than on new molecules.
State-of-the-art bsAb production – by evitria
evitria is at the forefront of bispecific antibody production and bispecific antibody production service, utilizing state-of-the-art techniques to deliver high-quality antibodies for both research and therapeutic applications. Specializing in the transient expression of antibodies in CHO cells, evitria offers a range of services tailored to meet the unique needs of their clients – from research groups to pharma companies and CDMOs. evitria combines advanced production methods with extensive expertise to ensure efficient and reliable antibody production.
evitria’s custom recombinant antibody production service also includes support in deciding on the most suitable bispecific antibody type, and is designed to accommodate various formats and technologies, such as Knobs-into-Hole and CrossMab, ensuring that each project meets your specific requirements.
Rescuing Unstable Candidates with Opti-mAb®
Having overseen tens of thousands of complex transfections, we know that advanced architectures, particularly those relying on single-chain variable fragments (scFvs), often face severe developability hurdles, including misfolding and aggregation. To secure your pipeline, evitria integrates our Opti-mAb® scFv Stabilization solution.
By structurally reinforcing the scFv domains within your specific formats (whether BiTEs, Knobs-into-Hole, or CrossMab), Opti-mAb® dramatically improves thermal stability and expression yields. This allows us to transform biologically active but unstable discovery hits into highly developable lead candidates.
Expert insight from evitria’s scientific team: what format diversity means for production
The diversity of formats among approved bispecifics means there is no one-size-fits-all production strategy. A tandem scFv, like blinatumomab or tarlatamab, can in principle be expressed in bacterial systems but requires refolding and lacks glycosylation. A DuoBody format requires separate expression of two parental IgGs followed by controlled Fab-arm exchange. A CrossMab requires co-expression of four distinct chains with domain crossover to ensure correct light-chain pairing.
In our experience, the most common production challenges map directly to the format. For multi-chain co-expression formats such as knobs-into-holes and CrossMab, chain ratio optimization is critical. For scFv-containing formats, scFv stability is the limiting factor. For DuoBody formats, the exchange reaction conditions and post-exchange purification define product quality. We have optimized our transient CHO platform for all of these workflows and can advise on format-specific production strategies, based on over 25,000 antibody expressions to date.
Julia Pizzolato, PhD
Read more about Bispecific Antibodies:
- Bispecific antibodies simply explained
- Understanding the side effects of bispecific antibodies
- Bispecific antibody formats
- What companies are developing bispecifc antibodies?
FAQs on FDA approved bispecific antibodies
FDA-approved bispecific antibodies are bispecific antibodies that have completed clinical trials and received marketing approval from the U.S. Food and Drug Administration. They span formats such as tandem scFv (BiTE®), DuoBody®, and CrossMab, and address indications from leukemia and lymphoma to solid tumors and hemophilia. The complete list is shown in the table above.
As of 2025, 15 bispecific antibodies have been approved by the FDA in the USA, ranging from blinatumomab (Blincyto®, 2014) to linvoseltamab (Lynozyfic®, 2025). The full list with targets and formats is shown in the table above.
Sources
- Blincyto®. Prescribing information. Amgen Inc; 2018. Accessed June 14, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125557s013lbl.pdf ↩︎
- Hemlibra®. Prescribing information. Genentech Inc; 2024. Accessed June 27, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761083s018lbl.pdf ↩︎
- Rybrevant®. Prescribing information. Janssen Biotech, Inc; 2021. Accessed July 9, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761210s000lbl.pdf ↩︎
- Kimmtrak®. Prescribing information. Immunocore Limited; 2022. Accessed July 9, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761228s000lbl.pdf ↩︎
- Vabysmo®. Prescribing information. Genentech Inc; 2022. Accessed June 14, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761235s000lbl.pdf ↩︎
- Tecvayli®. Prescribing information. Janssen Biotech, Inc; 2023. Accessed July 9, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761291s000lbl.pdf ↩︎
- Lunsumio®. Prescribing information. Genentech Inc; 2022. Accessed July 9, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761263s000lbl.pdf ↩︎
- Epkinly®. Prescribing information. Genmab US, Inc and AbbVie, Inc; 2023. Accessed July 9, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761324s000lbl.pdf ↩︎
- Columvi®. Prescribing information. Genentech Inc; 2023. Accessed July 9, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761309s000lbl.pdf ↩︎
- Talvey®. Prescribing information. Janssen Biotech, Inc; 2023. Accessed July 9, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761342s000lbl.pdf ↩︎
- Elrexfio®. Prescribing information. Pfizer Inc; 2023. Accessed July 9, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761345Orig1s000lbl.pdf ↩︎
- Imdelltra®. Prescribing information. Amgen Inc; 2024. Accessed July 9, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761344s000lbl.pdf ↩︎
- ZIIHERA®. Prescribing Information. Jazz Pharmaceuticals, Inc; 2024. Accessed July 10, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761416s000lbl.pdf ↩︎
- Zenocutuzumab (Bizengri®): Prescribing information. Merus US, Inc; 2024. Accessed December 4, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761352Orig1s000ltr.pdf ↩︎
- Linvoseltamab (Lynozyfic®): Prescribing information. Regeneron Pharmaceuticals, Inc; 2025. Accessed July 2, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761400s000lbl.pdf ↩︎
- Ulrich Brinkmann, Roland E Kontermann. The making of multispecific immunoglobulins – a clinical perspective. MAbs. 2026;18(1):2613548. doi:10.1080/19420862.2026.2613548. Accessed August 2026. https://pubmed.ncbi.nlm.nih.gov/41542910/ ↩︎