Biologics
Pulm Clinic · Clinician Reference
Biologics in Asthma & COPD
Approved monoclonal antibodies by molecular target, eligibility biomarker, dosing, and pivotal trials. Biomarker thresholds below are simplified label/trial-entry criteria — confirm against current FDA prescribing information and GINA 2025 / GOLD 2025 before prescribing.
Severe asthma
| Agent | Target | Eligible patients · key biomarker | Usual adult dose | Pivotal trials | Selected other indications |
|---|---|---|---|---|---|
| OmalizumabXolair | Anti-IgE | Allergic asthma ≥6 yr; perennial aeroallergen sensitization + serum IgE 30–700 IU/mL | SC q2–4 wk, weight/IgE-dosed | INNOVATE EXTRA | CRSwNP · chronic spontaneous urticaria · IgE-mediated food allergy |
| MepolizumabNucala | Anti-IL-5 | Eosinophilic phenotype ≥6 yr; BEC ≥150 current (or ≥300 in prior 12 mo) | 100 mg SC q4wk | MENSA SIRIUS DREAM | EGPA · HES · CRSwNP · COPD (eos) |
| ReslizumabCinqair | Anti-IL-5 | Eosinophilic phenotype ≥18 yr; BEC ≥400 | 3 mg/kg IV q4wk | Castro 2015 (2 replicate ph3) | — (IV only; weight-based; niche use) |
| BenralizumabFasenra | Anti-IL-5Rα | Eosinophilic phenotype ≥6 yr; near-complete eosinophil depletion (ADCC) | 30 mg SC q4wk ×3, then q8wk | SIROCCO CALIMA ZONDA | EGPA (MANDARA, 2024) |
| DupilumabDupixent | Anti-IL-4Rα | Mod–severe ≥6 yr; eosinophilic phenotype (BEC ≥150) or OCS-dependent; ↑FeNO supportive | 200 or 300 mg SC q2wk | QUEST VENTURE | Atopic dermatitis · CRSwNP · EoE · prurigo nodularis · COPD (eos) |
| TezepelumabTezspire | Anti-TSLP | Severe asthma ≥12 yr; no biomarker/phenotype requirement (benefit across BEC strata) | 210 mg SC q4wk | NAVIGATOR PATHWAY SOURCE* | — (CRSwNP under study) |
*SOURCE (OCS-sparing) missed its primary endpoint; included for completeness. BEC = blood eosinophil count (cells/µL).
COPD — eosinophilic phenotype
Both approved COPD biologics are add-on to optimized inhaled therapy in patients who still exacerbate. They are not rescue or monotherapy, and the eligibility eosinophil threshold differs between the two agents.
| Agent | Target | Eligible patients · key biomarker | Usual dose | Pivotal trials (exacerbation Δ) | Status |
|---|---|---|---|---|---|
| DupilumabDupixent | Anti-IL-4Rα | Inadequately controlled COPD + eosinophilic phenotype, BEC ≥300, on triple therapy (or LABA/LAMA if ICS inappropriate) | 300 mg SC q2wk | BOREAS −30% NOTUS −34% | First biologic approved for COPD · FDA Sep 2024 |
| MepolizumabNucala | Anti-IL-5 | Inadequately controlled COPD + eosinophilic phenotype, BEC ≥150, on optimized inhaled therapy | 100 mg SC q4wk | MATINEE −21% METREX | FDA approved May 2025 |
- Benralizumab (anti-IL-5Rα): negative as maintenance therapy (GALATHEA / TERRANOVA). The ABRA trial showed benefit treating acute eosinophilic exacerbations — a different use, still investigational.
- Tezepelumab (anti-TSLP): COURSE (phase 2a) missed its primary endpoint; a possible signal at higher BEC awaits a phase 3 trial.
- Itepekimab (anti-IL-33) and astegolimab (anti-ST2): mixed / ongoing phase 2–3 data.
Phenotype-first selection
Asthma
Allergic + ↑IgE → omalizumab
Eosinophilic → IL-5 pathway (mepolizumab · reslizumab · benralizumab) or dupilumab (also for OCS-dependent / ↑FeNO)
Biomarker-independent / low-T2 or mixed → tezepelumab
COPD
Optimize triple inhaled therapy first; biologics are add-on for persistent exacerbations.
BEC ≥300 → dupilumab
BEC ≥150 → mepolizumab
No allergic or biomarker-independent option is approved in COPD.
Shared mechanism note. All target the type 2 inflammatory axis. IL-5 / IL-5Rα agents act on eosinophil survival; dupilumab blocks shared IL-4/IL-13 signaling (broader type 2 reach); tezepelumab acts upstream at the epithelial alarmin TSLP, which is why it does not require an eosinophil threshold in asthma.
Scope & safety. Dosing shown is the common adult maintenance regimen; omalizumab and dupilumab use weight / IgE / age bands not fully captured here. This reference does not replace the FDA prescribing information or a clinician's judgment for the individual patient.
Sources. FDA prescribing information; pivotal trial publications (linked); GINA 2025; GOLD 2025; NEJM (BOREAS, NOTUS, MATINEE, METREX, MANDARA); Lancet Respiratory Medicine (COURSE). Trial links resolve to PubMed and are maintained by acronym.
Last reviewed June 2026 · BokaMD Pulm Clinic · Compiled for clinician reference; verify against current labeling before prescribing.
