Dupixent (dupilumab, Regeneron/Sanofi) and Ebglyss (lebrikizumab, Eli Lilly) are two injectable biologics approved for moderate-to-severe atopic dermatitis. Dupixent targets the shared IL-4Ralpha receptor, blocking both IL-4 and IL-13 signaling. Ebglyss selectively targets IL-13 with high binding affinity. Both are effective, but their access trajectories are very different.
Dupixent was first approved in 2017 and has since expanded to nine indications including asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, bullous pemphigoid, COPD, chronic spontaneous urticaria, and allergic fungal rhinosinusitis. Ebglyss was approved in September 2024 for atopic dermatitis only. Most major payers require patients to try and fail Dupixent before approving Ebglyss, making it a second-line biologic in practice.
This comparison is for dermatologists, allergists, immunologists, prior authorization coordinators, and access teams who need to understand how these two products compare on label, safety, cost, and coverage — and what those differences mean for the patient in front of them.
Short answer
| Dupixent (dupilumab) | Ebglyss (lebrikizumab) | |
|---|---|---|
| Drug class | IL-4Ralpha antagonist (blocks IL-4 and IL-13) | IL-13 antagonist (selective) |
| Manufacturer | Regeneron / Sanofi | Eli Lilly |
| Route | Subcutaneous injection (prefilled pen or syringe) | Subcutaneous injection (prefilled pen or syringe) |
| FDA indications | 9 (AD, asthma, CRSwNP, EoE, PN, BP, COPD, CSU, AFRS) | 1 (atopic dermatitis) |
| Approved ages (AD) | 6 months and older | 12 years and older (weighing at least 40 kg) |
| Dose frequency (AD maintenance) | 300 mg every 2 weeks | 250 mg every 4 weeks |
| Boxed warning | No | No |
| Biosimilar competition | None (but Stapokibart approved in China) | None |
| Formulary access | Near-universal commercial coverage (~99%) | Step-through Dupixent required at most payers |
| PA required | Yes, but streamlined at most payers | Yes, with step-through Dupixent or Rinvoq |
Mechanism and clinical differentiation
Dupixent is a fully human monoclonal antibody targeting the IL-4Ralpha subunit shared by receptors for both IL-4 and IL-13. By blocking this shared receptor, Dupixent inhibits type 2 inflammation driven by both cytokines across multiple organ systems. This broad mechanism underpins its nine approved indications spanning dermatology, pulmonology, gastroenterology, and other specialties.
Ebglyss is a monoclonal antibody that selectively targets IL-13 with high binding affinity and slow dissociation rate. It binds to IL-13 at an area that overlaps with the IL-4Ralpha binding site, preventing formation of the IL-13Ralpha1/IL-4Ralpha heterodimer and inhibiting IL-13 signaling. IL-13 is considered a primary driver of the type 2 inflammatory loop in atopic dermatitis.
The clinical significance for access: Ebglyss's selective IL-13 targeting means it is being studied primarily in atopic dermatitis. It does not have the multi-indication portfolio that makes Dupixent a "first-line biologic" across so many therapeutic areas.
FDA-approved indications comparison
| Indication | Dupixent | Ebglyss |
|---|---|---|
| Atopic dermatitis (moderate-to-severe) | Yes (age 6 months+) | Yes (age 12+, weight >= 40 kg) |
| Asthma (moderate-to-severe, eosinophilic phenotype) | Yes (age 6+) | No |
| Chronic rhinosinusitis with nasal polyps | Yes (age 12+) | No |
| Eosinophilic esophagitis | Yes (age 1+) | No |
| Prurigo nodularis | Yes (adults) | No |
| Bullous pemphigoid | Yes (adults) | No |
| COPD | Yes (adults) | No |
| Chronic spontaneous urticaria | Yes (age 12+) | No |
| Allergic fungal rhinosinusitis | Yes (age 6+, history of sino-nasal surgery) | No |
Dupixent's breadth of indications gives it a significant formulary advantage. Payers that cover Dupixent for any of its nine indications have a strong incentive to keep it as the preferred biologic for atopic dermatitis, since the same patient may need it for overlapping conditions.
Dosing and administration
| Parameter | Dupixent (AD) | Ebglyss (AD) |
|---|---|---|
| Loading dose | 600 mg (two 300 mg injections) on Day 1 | 500 mg (two 250 mg injections) at Week 0 and Week 2 |
| Induction dose | 300 mg every 2 weeks | 250 mg every 2 weeks through Week 16+ |
| Maintenance dose | 300 mg every 2 weeks | 250 mg every 4 weeks |
| Available as | Prefilled pen (300 mg/2 mL, 200 mg/1.14 mL); prefilled syringe | Prefilled pen (250 mg/2 mL); prefilled syringe |
| Injection sites | Abdomen, thigh, upper arm (by caregiver) | Abdomen, thigh, upper arm (by caregiver) |
Ebglyss has a practical dosing advantage in maintenance: one injection every four weeks versus Dupixent's every two weeks. Phase 3 extension data (ADjoin trial, presented October 2025) also showed that Ebglyss maintained efficacy when dosed every eight weeks in responders, potentially supporting an even less frequent maintenance option.
Efficacy comparison
Head-to-head trial data between Dupixent and Ebglyss in atopic dermatitis is limited. Cross-trial comparisons should be interpreted cautiously:
| Endpoint | Dupixent (SOLO 1/2, pooled) | Ebglyss (ADVOCATE 1/2, pooled) |
|---|---|---|
| IGA 0/1 at Week 16 | 36-38% | 33-35% |
| EASI-75 at Week 16 | 48-52% | 58-67% |
| Pruritus NRS >=4-point improvement | 37-40% | 48-53% |
Cross-trial comparison is limited by differences in patient populations, concomitant therapies, and trial design. Ebglyss showed higher EASI-75 and pruritus improvement rates in its trials, but this does not establish superiority in the absence of a direct head-to-head study.
Maintenance durability
The ADjoin Phase 3 extension trial (presented October 2025) demonstrated that Ebglyss maintained similar skin clearance whether dosed every 4 weeks or every 8 weeks, supporting a potential less frequent maintenance option for patients who achieve adequate response.
Safety comparison
| Adverse reaction | Dupixent | Ebglyss |
|---|---|---|
| Conjunctivitis/keratitis | 10-15% (higher than placebo) | 6.6% (higher than placebo at 1.6%) |
| Injection site reactions | Common (5-10%) | Common (1-5%) |
| Headache | 5-7% | 4.3% |
| Herpes zoster | Uncommon | >= 1% |
| Hypersensitivity | Rare | Rare |
| Boxed warning | No | No |
Conjunctivitis is the most notable adverse event for both drugs but occurs at a higher rate with Dupixent. Neither drug carries a boxed warning, which differentiates them from oral JAK inhibitors used in atopic dermatitis (Rinvoq, Cibinqo) that carry boxed warnings for infections, malignancy, MACE, and thrombosis.
Payer and PBM coverage
Commercial insurance
The access gap between Dupixent and Ebglyss is significant:
Dupixent coverage:
- Approximately 99% of commercial atopic dermatitis patients (age 6 months+) are covered for Dupixent nationally.
- Approximately 90% of commercial patient lives require failure of only 1-2 topical treatments before Dupixent approval.
- Most major payers (UnitedHealthcare, Cigna, BCBS plans) have Dupixent on formulary as a preferred or Tier 2 biologic for AD.
Ebglyss coverage:
- UnitedHealthcare (commercial): Requires trial and failure of Dupixent (dupilumab) AND a JAK inhibitor (e.g., Rinvoq, Cibinqo) before approving Ebglyss. Effective May 2025.
- Kaiser Permanente Northwest: Ebglyss is non-formulary. Requires trial and failure of Dupixent (Adbry), AND Adbry (tralokinumab), AND Nemluvio (nemolizumab). Effective July 2025.
- Alaska Medicaid: Requires trial and failure of at least two topical therapies. Does not require prior biologic failure. Effective March 2026.
- EOCCO: Requires trial of Dupixent or Rinvoq before Ebglyss. Effective January 2026.
- BCBS Massachusetts: Ebglyss requires PA. Dupixent is also PA required. Both listed as formulary options with step-through topicals first.
- Premera: Updated December 2025 to require inadequate response or intolerance to Adbry, Dupixent, Ebglyss, or Rinvoq before covering non-formulary alternatives.
The pattern is clear: most major payers position Ebglyss as a second-line or later biologic, requiring Dupixent failure first. This is a formulary decision, not an FDA label requirement.
Medicare Part D
Dupixent is widely covered on Medicare Part D formularies as a specialty tier drug. Ebglyss coverage under Part D is still being established, but most plans that cover it are expected to apply similar step-through requirements as commercial plans.
Step therapy hierarchy
The typical payer step therapy ladder for atopic dermatitis biologics in 2026:
| Step | Therapy |
|---|---|
| Step 1 | Topical corticosteroids (medium/high potency, 30+ days) |
| Step 2 | Topical calcineurin inhibitor or crisaborole |
| Step 3 | Dupixent (first-line biologic at most payers) |
| Step 4 | Ebglyss or Rinvoq or Adbry (after Dupixent failure) |
Some payers allow Step 3 to be Dupixent OR Rinvoq (JAK inhibitor), then Step 4 is Ebglyss. Others require Dupixent specifically before Ebglyss.
Pricing and cost considerations
Wholesale acquisition cost
Neither manufacturer publishes WAC in a format easily comparable across payers, but both are priced as specialty biologics:
- Dupixent's WAC is approximately $3,800-$4,200 per 300 mg injection (two injections per dose at 600 mg loading, then one injection per dose at 300 mg maintenance every 2 weeks).
- Ebglyss's WAC is approximately $3,800-$4,200 per 250 mg injection (two injections at loading, then one injection per dose at 250 mg every 2-4 weeks maintenance).
The annualized cost difference depends on maintenance frequency. Ebglyss's every-4-week maintenance dosing (after induction) translates to 13 maintenance injections per year versus Dupixent's 26 maintenance injections per year — a potential cost advantage if payers cover the product.
Patient assistance
- Dupixent MyWay: Copay assistance, patient support, and bridge programs. Many commercially insured patients pay $0 out-of-pocket. Regeneron/Sanofi also offer a patient assistance program for uninsured patients.
- Ebglyss support: Lilly offers copay assistance and patient support. Patients should check the manufacturer's website for current programs.
What to monitor
- Ebglyss indication expansion: Lilly may pursue additional indications for lebrikizumab (e.g., asthma, CRSwNP). Additional indications would strengthen formulary positioning. Dupixent continues to expand its own label, most recently with AFRS approval in February 2026.
- Every-8-week dosing data: The ADjoin trial data supporting Q8W dosing could be submitted to FDA. If approved, less frequent dosing would be a meaningful competitive advantage.
- Payer tier movement: Monitor whether any major payer moves Ebglyss to first-line biologic status (without requiring Dupixent failure first). This would significantly expand access.
- Competitive landscape: Additional atopic dermatitis biologics (Nemluvio, and pipeline agents from Apogee Therapeutics and others) may shift the step therapy hierarchy.
- Dupixent biosimilar threat: Stapokibart, an IL-4Ralpha biosimilar-like product, was approved in China in September 2024. Monitor whether this signals future biosimilar competition for Dupixent in the US.
Sources
- FDA. Ebglyss (lebrikizumab-lbkz) Prescribing Information. Revised May 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761306s003lbl.pdf
- FDA. Dupixent (dupilumab) Prescribing Information. February 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761055s075lbl.pdf
- Eli Lilly. FDA Approves Lilly's EBGLYSS (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis. September 13, 2024. https://www.prnewswire.com/news-releases/fda-approves-lillys-ebglyss-lebrikizumab-lbkz-for-adults-and-children-12-years-and-older-with-moderate-to-severe-atopic-dermatitis-302248062.html
- Eli Lilly. EBGLYSS (lebrikizumab-lbkz) Delivered Durable Disease Control When Administered Once Every Eight Weeks. October 24, 2025. https://www.prnewswire.com/news-releases/lillys-ebglyss-lebrikizumab-lbkz-delivered-durable-disease-control-when-administered-once-every-eight-weeks-in-patients-with-moderate-to-severe-atopic-dermatitis-302593427.html
- UnitedHealthcare. Ebglyss Prior Authorization/Medical Necessity Policy. Program 2025 P 2367-1. Effective May 2025.
- Kaiser Permanente Northwest. Lebrikizumab-lbkz (Ebglyss) Criteria for Drug Coverage. Effective July 2025.
- Alaska Medicaid. Ebglyss Prior Authorization Criteria. Effective March 2026.
- EOCCO. Lebrikizumab (Ebglyss) Policy. EOCCO310. Updated January 2026.
- BCBS Massachusetts. Immunomodulators for Skin Conditions. Policy 010. Updated December 2025.
- Premera. Pharmacologic Treatment of Atopic Dermatitis. Policy 5.01.628. Updated December 2025.
- Dupixent HCP. Formulary Coverage Tool. Accessed May 2026. https://www.dupixenthcp.com/atopicdermatitis/resources/formulary-coverage
- Drugs.com. Ebglyss: Uses, Dosage, Side Effects. Updated March 2026.
- Patsnap Eureka. Dupilumab Competitive Landscape: Type 2 Inflammation Market Analysis 2026.
- Dermatology Advisor. Spotlight on Biologic Therapies for Atopic Dermatitis at AAD 2025.
- Regeneron/Sanofi. Dupixent (dupilumab) Approved in the U.S. as the First and Only Medicine for Allergic Fungal Rhinosinusitis (AFRS). February 24, 2026. https://newsroom.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-us-first-and-only-medicine-allergic
