Reference

Agent formulary

Licensed initiation criteria follow the ACCP clinical practice guideline table. Indian regulatory status is stated separately because it diverges materially from the FDA/EMA position.

Omalizumab

Xolair; biosimilars incl. Omlyclo

Anti-IgEMarketed in India

Cytokines: IgE, IL-4 (upstream of class switch)
Route: Subcutaneous
Interval: Every 2 or 4 weeks — dose set by baseline IgE and body weight
From age: 6 years
Comorbid: CRSwNP; chronic spontaneous urticaria; IgE-mediated food allergy
India: Long established in India, with biosimilar competition now easing cost.

Mepolizumab

Nucala

Anti-IL-5Marketed in India

Cytokines: IL-5
Route: Subcutaneous
Interval: Every 4 weeks
From age: 6 years
Comorbid: CRSwNP; EGPA; hypereosinophilic syndrome; eosinophilic COPD (US/EU — confirm Indian label)
India: Available; Indian Phase IV experience published (PRISM).

Benralizumab

Fasenra

Anti-IL-5RαMarketed in India

Cytokines: IL-5Rα (ADCC eosinophil depletion)
Route: Subcutaneous
Interval: Every 4 weeks × 3 doses, then every 8 weeks
From age: 6 years
Comorbid: EGPA (monthly regimen); hypereosinophilic syndrome (US)
India: Marketed in India by AstraZeneca. A local safety study has been conducted in Indian patients, and the 8-weekly maintenance interval makes it the least demanding of the domestically available schedules.

Depemokimab

Exdensur

Anti-IL-5 (ultra-long-acting)Not approved in India

Cytokines: IL-5
Route: Subcutaneous
Interval: Every 26 weeks — two doses per year
From age: 12 years
Comorbid: CRSwNP under regulatory review
India: FDA approved 16 December 2025 and licensed by the MHRA; no Indian marketing authorisation. Named-patient import only.

Reslizumab

Cinqair

Anti-IL-5Not marketed in India

Cytokines: IL-5
Route: Intravenous
Interval: Weight-based, every 4 weeks
From age: 18 years
Comorbid: None
India: Never commercialised in India; intravenous route and an anaphylaxis boxed warning have limited uptake everywhere.

Dupilumab

Dupixent

Anti-IL-4Rα (blocks IL-4 and IL-13)Marketed in India

Cytokines: IL-4, IL-13
Route: Subcutaneous
Interval: Every 2 weeks after a loading dose
From age: 6 years
Comorbid: Atopic dermatitis; CRSwNP; eosinophilic oesophagitis; COPD with eosinophils ≥300 cells/µL; prurigo nodularis; bullous pemphigoid
India: Available, across its dermatology and respiratory indications.

Tezepelumab

Tezspire

Anti-TSLP (epithelial alarmin)Not approved in India

Cytokines: TSLP
Route: Subcutaneous
Interval: Every 4 weeks
From age: 12 years
Comorbid: CRSwNP (US)
India: The CDSCO Subject Expert Committee (Pulmonary), meeting 16 December 2025, reiterated that AstraZeneca must run a local Phase III study in Indian adults before import and marketing can be considered — noting India was not a participating country in NAVIGATOR, DESTINATION or DIRECTION, and finding no unmet need over current standard of care. Access is therefore named-patient only.

Initiation criteria at a glance

Agent	Target	Criteria for initiation	Dosing	India
Omalizumab	Anti-IgE	Uncontrolled symptoms of allergic asthma with sensitisation to a perennial aeroallergen despite ICS use.	Every 2 or 4 weeks — dose set by baseline IgE and body weight	Marketed in India
Mepolizumab	Anti-IL-5	Eosinophilic asthma, blood eosinophils ≥150 cells/µL, with ≥2 exacerbations per year despite ICS-LABA.	Every 4 weeks	Marketed in India
Benralizumab	Anti-IL-5Rα	Eosinophilic asthma, blood eosinophils ≥300 cells/µL, with ≥2 exacerbations per year despite medium-to-high dose ICS-LABA.	Every 4 weeks × 3 doses, then every 8 weeks	Marketed in India
Depemokimab	Anti-IL-5 (ultra-long-acting)	Asthma with an eosinophilic phenotype on medium-to-high dose ICS plus another controller.	Every 26 weeks — two doses per year	Not approved in India
Reslizumab	Anti-IL-5	Eosinophilic asthma with blood eosinophils ≥400 cells/µL despite at least medium-dose ICS.	Weight-based, every 4 weeks	Not marketed in India
Dupilumab	Anti-IL-4Rα (blocks IL-4 and IL-13)	Eosinophilic asthma with blood eosinophils ≥150 cells/µL, or steroid dependency, or exacerbations despite medium-to-high dose ICS-LABA.	Every 2 weeks after a loading dose	Marketed in India
Tezepelumab	Anti-TSLP (epithelial alarmin)	Uncontrolled asthma despite medium-to-high dose ICS-LABA — no phenotype or biomarker restriction in the label.	Every 4 weeks	Not approved in India

Pipeline — not scored

Itepekimab

Anti-IL-33

Epithelial alarmin, parallel to TSLP. Phase 3 in COPD and asthma. Not scored — no licensed asthma indication yet.

Astegolimab

Anti-ST2 (IL-33 receptor)

Blocks IL-33 signalling at the receptor. Investigational.