Atopic Dermatitis: Ebglys Joins Reimbursed Biologics Market

Starting in July, Ebglys (lebrikizumab) will be covered by Korea’s national health insurance, initiating a three-way market competition with existing biologics Dupixent (dupilumab) and Adtralza (tralokinumab) in the treatment of atopic dermatitis (AD).

On June 19, the Ministry of Health and Welfare (MOHW) issued a pre-announcement regarding a partial revision to the Detailed Criteria and Methods for Application of Health Insurance Benefits (Drugs).

Under the new policy, Ebglys will be reimbursed for adults and adolescents (12–17 years, ≥40 kg) with persistent AD symptoms for over three years who meet all of the following criteria:

① Inadequate symptom control after at least four weeks of topical therapy (moderate-to-high potency corticosteroids or calcineurin inhibitors)

② Lack of efficacy (<50% EASI improvement) or treatment discontinuation due to side effects after three months of systemic immunosuppressants (cyclosporine or methotrexate)

③ Baseline EASI score of ≥23 before Ebglys initiation

Patients who fail to respond to Ebglys or experience adverse events may be switched to a JAK inhibitor upon submission of a physician’s statement.

With this reimbursement decision, the stage is set for full-scale competition among reimbursed biologics starting in July.

Dupixent leads Korea’s AD biologics market and is approved for patients from six months of age through adulthood. Its broad reimbursement coverage and eligibility for co-payment reduction programs have driven widespread clinical adoption.

Targeting both IL-4 and IL-13, Dupixent modulates type 2 inflammation and is approved for multiple indications including: Atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, and chronic obstructive pulmonary disease (COPD)

Unlike JAK inhibitors, Dupixent is considered safe for elderly patients, those at high cardiovascular risk, or with cancer concerns—populations for whom JAK inhibitors are often avoided.

Long-term safety is supported by over five years of clinical data and extensive real-world experience since its AD launch in 2020, strengthening physician confidence in its sustained efficacy.

Adtralza, launched in 2024, is a monoclonal antibody that selectively targets IL-13. Unlike Dupixent, which blocks both IL-4 and IL-13, Adtralza is designed to maximize IL-13 inhibition while avoiding IL-4-related side effects.

LEO Pharma emphasizes Adtralza’s efficacy in addressing head and neck lesions—an area with lingering unmet needs among Dupixent users.

Results from the global TRACE real-world study (167 sites in 11 countries) showed a reduction in patients with head and neck involvement from 67% at 3 months to 52% at 9 months.

Adtralza has also demonstrated a lower incidence of conjunctivitis, a common Dupixent side effect, and maintained both efficacy and safety in long-term studies.

These benefits were reinforced in the ECZTRA 1/2 trials and their extension (ECZTEND), supporting Adtralza’s role in patients needing long-term disease control, especially those with severe ocular symptoms or facial involvement.

Ebglys, like Adtralza, targets IL-13 but binds only to IL-13Rα1—unlike Adtralza, which also blocks the decoy receptor IL-13Rα2. According to Eli Lilly, this selectivity allows IL-13Rα2 to remain active, potentially enhancing IL-13 clearance in skin tissue while reducing side effects.

In Phase 3 trials (ADvocate-1 and ADvocate-2), Ebglys showed strong efficacy:

IGA 0/1 (clear/almost clear skin) rates were 43.1% and 33.2% at week 16, versus 12.7% and 10.8% in placebo groups (p<0.001).

EASI-75 and EASI-90 responses reached 58.8% and 38.3%, outperforming placebo (52.1% and 30.7%).

Ebglys is also being recognized for its dosing convenience. While Dupixent is administered biweekly, both Adtralza and Ebglys offer monthly regimens. Moreover, Ebglys requires only a single injection per cycle, compared to Adtralza’s two, potentially improving adherence, especially among adolescents.

Despite its launch in January, limited real-world data has slowed clinical uptake. Lilly is working to address this gap through ongoing global studies and plans to publish data on Dupixent non-responders treated with Ebglys.