Monoclonal antibodies (mAbs) are one of the fastest-growing segments in biopharmaceuticals, with applications ranging from cancer therapy to autoimmune disease management. By 2025, more than 130 antibody-based drugs have been approved by the U.S. Food and Drug Administration (FDA), reflecting their critical role in modern medicine. Among this expanding list, some stand out due to their clinical impact, innovative mechanisms of action, and commercial success. This blog highlights ten FDA-approved therapeutic antibodies that researchers, clinicians, and biotech professionals should know about in 2025.

1. Adalimumab (Humira)

• Target: TNF-α
• Indications: Rheumatoid arthritis (RA), psoriasis, inflammatory bowel disease (IBD), uveitis
• Why it matters: Humira remains one of the highest-selling biologics worldwide and has paved the way for multiple biosimilars. Its success has driven innovation in anti-TNF therapies.

2. Nivolumab (Opdivo)

• Target: PD-1 (Programmed Death-1 receptor)
• Indications: Melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, multiple other cancers
• Why it matters: Nivolumab was one of the first immune checkpoint inhibitors approved, revolutionizing cancer immunotherapy by unleashing the body’s own immune system to fight tumors.

3. Pembrolizumab (Keytruda)

• Target: PD-1
• Indications: Wide range of cancers including melanoma, NSCLC, head and neck squamous cell carcinoma, MSI-H cancers
• Why it matters: Pembrolizumab is notable for its tissue-agnostic approval – it can be used for any solid tumor with high microsatellite instability (MSI-H), a landmark shift in oncology treatment.

4. Trastuzumab (Herceptin)

• Target: HER2 (human epidermal growth factor receptor 2)
• Indications: HER2-positive breast cancer and gastric cancer
• Why it matters: Trastuzumab changed the prognosis for HER2-positive breast cancer patients, turning a once aggressive subtype into a treatable disease.

5. Erenumab (Aimovig)

• Target: CGRP receptor (Calcitonin Gene-Related Peptide receptor)
• Indications: Migraine prevention
• Why it matters: Erenumab represents the first FDA-approved antibody for migraine prevention, offering a targeted approach for millions of patients with chronic migraines.

6. Bevacizumab (Avastin)

• Target: VEGF-A (Vascular Endothelial Growth Factor)
• Indications: Colorectal cancer, lung cancer, renal cancer, glioblastoma
• Why it matters: Bevacizumab is a pioneer anti-angiogenic therapy, blocking blood vessel growth that feeds tumors, and is used in multiple solid tumor regimens.

7. Secukinumab (Cosentyx)

• Target: IL-17A
• Indications: Psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis
• Why it matters: Secukinumab provided one of the first highly effective IL-17A blockade therapies, achieving clear skin in a large proportion of psoriasis patients.

8. Daratumumab (Darzalex)

• Target: CD38
• Indications: Multiple myeloma
• Why it matters: Daratumumab was the first monoclonal antibody approved for multiple myeloma, offering both monotherapy and combination therapy options that significantly improve survival.

9. Dupilumab (Dupixent)

• Target: IL-4Rα (Interleukin-4 receptor alpha)
• Indications: Atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis
• Why it matters: Dupilumab is a breakthrough in atopic disease treatment, reducing steroid dependence and improving quality of life for patients with severe allergic conditions.

10. Teplizumab (Tzield)

• Target: CD3
• Indications: Delay of Type 1 diabetes onset in at-risk individuals
• Why it matters: Teplizumab is the first disease-modifying therapy for type 1 diabetes, delaying clinical onset by preserving pancreatic beta-cell function.

The Bigger Picture

These ten antibodies represent diverse therapeutic strategies – from immune checkpoint inhibition and cytokine modulation to receptor blockade and angiogenesis inhibition. Together, they illustrate how antibody therapeutics are shaping the future of medicine, offering targeted, personalized solutions to some of the most challenging diseases.

Conclusion

As of 2025, therapeutic antibodies continue to dominate the biologics market, with innovations extending into bispecific antibodies, antibody-drug conjugates (ADCs), and Fc-engineered molecules. Understanding these key FDA-approved antibodies helps researchers and clinicians stay informed about standard-of-care treatments and inspires the next wave of antibody drug discovery.