Last reviewed 2026-04-20 · How we verify

SARILUMAB

Sarilumab inhibits IL-6 signaling by binding to both soluble and membrane-bound IL-6 receptors.

Sarilumab is a marketed drug for Rheumatoid Arthritis that inhibits IL-6 signaling by binding to both soluble and membrane-bound IL-6 receptors. Its key strength lies in its mechanism of action, which targets both forms of IL-6 receptors, potentially offering broader efficacy compared to competitors. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics and biosimilars.

At a glance

Mechanism of action

Sarilumab works by binding to IL-6 receptors, which prevents the cytokine IL-6 from activating these receptors. This inhibition reduces the inflammatory response associated with conditions like rheumatoid arthritis.

Approved indications

• Rheumatoid Arthritis
• Polymyalgia Rheumatica
• Polyarticular Juvenile Idiopathic Arthritis

Boxed warnings

• WARNING: RISK OF SERIOUS INFECTIONS Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) ]. Opportunistic infections have also been reported in patients receiving KEVZARA. Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid use of KEVZARA in patients with an active infection. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before KEVZARA use and during therapy. Treatment for latent infection should be initiated prior to KEVZARA use. Invasive fungal infections, such as candidiasis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral and other infections due to opportunistic pathogens. Closely monitor patients for signs and symptoms of infection during treatment with KEVZARA. If a serious infection develops, interrupt KEVZARA until the infection is controlled. Consider the risks and benefits of treatment with KEVZARA prior to initiating therapy in patients with chronic or recurrent infection. WARNING: RISK OF SERIOUS INFECTIONS See full prescribing information for complete boxed warning . Serious infections leading to hospitalization or death including bacterial, viral, invasive fungal, and other opportunistic infections have occurred in patients receiving KEVZARA. ( 5.1 ) If a serious infection develops, interrupt KEVZARA until the infection is controlled. ( 5.1 ) Cases of tuberculosis (TB) have been reported. Prior to starting KEVZARA, test for latent TB; if positive, start treatment for TB. ( 5.1 ) Closely monitor patients for signs and symptoms of infection during treatment with KEVZARA. ( 5.1 )

Common side effects

• neutropenia
• increased ALT
• injection site erythema
• upper respiratory infections
• urinary tract infections
• neutropenia
• leukopenia
• injection site pruritus
• nasopharyngitis
• upper respiratory tract infection
• injection site erythema

Drug interactions

• JAK inhibitors or biological DMARDs such as TNF antagonists
• CYP450 substrates
• CYP3A4 substrate drugs (e.g., oral contraceptives, lovastatin, atorvastatin)
• Live vaccines

Key clinical trials

• A Study to Investigate Ubamatamab With and Without REGN7075 in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) (PHASE2)
• IL6-receptor Inhibitor Iwith Belumosudil for the Treatment of Belumosudil-refractory cGVHD (PHASE1)
• I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (PHASE2)
• A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS) (PHASE2)
• A Dose Finding Phase 1 of Sarilumab Plus Capecitabine in HER2/Neu-Negative Metastatic Breast Cancer and a Single-arm, Historically-controlled Phase 2 Study of Sarilumab Plus Capecitabine in Stage I-III Triple Negative Breast Cancer With High-Risk Residual Disease (EMPOWER) (PHASE1, PHASE2)
• A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer (PHASE1, PHASE2)
• Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer (PHASE2)
• Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• SARILUMAB CI brief — competitive landscape report
• SARILUMAB updates RSS · CI watch RSS