Bispecific antibodies (BsAbs) are a class of engineered antibodies designed to bind to two distinct antigens simultaneously, setting them apart from monoclonal antibodies in the comparison of monoclonal vs bispecific antibody. Unlike monoclonal antibodies, which have two identical binding arms targeting a single antigen, BsAbs feature two unique binding domains, enabling precise therapeutic interventions by engaging multiple molecular pathways or cell types, such as cancer cells and immune cells, at the same time. Developed in advanced laboratory settings, bispecific antibody therapy is pivotal in advancing cancer treatment and imaging due to its enhanced specificity and efficacy.
In contrast to standard immunotherapy drugs, which typically consist of antibody molecules with a single receptor targeting one antigen, BsAbs, supported by innovative bispecific antibody platforms, allow for addressing complex diseases by simultaneously targeting tumor cells and immune system components, such as T cells, to enhance immune responses against cancer. Their applications span various cancers, including acute lymphoblastic leukemia (ALL), non-small-cell lung carcinoma (NSCLC), relapsed or refractory follicular lymphoma (R/R FL), relapsed or refractory multiple myeloma (R/R MM), and relapsed or metastatic cervical cancer (R/M CC).
The global market for BsAbs underscores their growing importance, driven by leading bispecific antibody companies like Roche, Amgen, and Johnson & Johnson. In 2024, Roche’s Hemlibra, used for preventing or reducing bleeds in hemophilia A, led sales with approximately $5.361 billion, while Vabysmo, a bispecific eye injection for conditions like wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), generated $4.6 billion. Other approved BsAbs, such as Amgen’s Blincyto for ALL, Johnson & Johnson’s Rybrevant for NSCLC, and Immunocore’s Kimmtrak for uveal melanoma, target diverse indications, showcasing the broad therapeutic potential of BsAbs. By 2025, 18 BsAbs have been approved globally, including therapies like Columvi and Lunsumio (Roche) for relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) and Akeso’s Ivonescimab for NSCLC, with contributions from platforms like Regeneron’s bispecific platform.
BsAbs operate through various mechanisms, such as T cell engagers (e.g., Blincyto, targeting CD19/CD3ε), dual signaling inhibitors (e.g., Rybrevant, targeting EGFR/c-Met), or factor mimetics (e.g., Hemlibra, mimicking factor VIII). These mechanisms enhance their ability to orchestrate targeted immune responses or inhibit multiple disease pathways simultaneously. However, BsAbs can pose challenges, as their ability to both activate and suppress the immune system may lead to side effects, including autoimmune reactions like myocarditis, hepatitis, or pneumonitis, where the immune system may inadvertently attack healthy tissues.
While distinct from antibody-drug conjugates (ADCs), which deliver cytotoxic drugs to specific cells, BsAbs share innovative potential with bispecific antibody drug conjugates (BsADCs). Research is underway exploring bispecific ADCs, combining dual-targeting capabilities with drug delivery for enhanced therapeutic outcomes. With over a dozen ADCs in early clinical studies and ongoing advancements in BsAb technology, these therapies hold significant promise for treating a wide range of diseases, particularly cancers, by offering more precise and effective treatment options.
References
Ray, Christina M. P., et al. “Mechanistic Computational Modeling of Monospecific and Bispecific Antibodies Targeting Interleukin-6/8 Receptors.” PLoS Computational Biology, vol. 20, no. 6, 7 June 2024, pp. 1–25, doi:10.1371/journal.pcbi.1012157.
Sun, Yanan, et al. “Bispecific Antibodies in Cancer Therapy: Target Selection and Regulatory Requirements.” Acta Pharmaceutica Sinica B, vol. 13, no. 9, Sept. 2023, pp. 3583–97, doi:10.1016/j.apsb.2023.05.023.
Surowka, Marlena, and Christian Klein. “A Pivotal Decade for Bispecific Antibodies?” mAbs, vol. 16, no. 1, 11 Mar. 2024, pp. 1–15, doi:10.1080/19420862.2024.2321635. Erratum in: mAbs, vol. 16, no. 1, 2024, doi:10.1080/19420862.2024.2335597.
Updated: Oct 22, 2025
