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aBLA Filing Intelligence & Biosimilar Opportunity

Tezspire

Tezepelumab-Ekko
Respiratory agents
Subcutaneous Solution

Biologics transformed severe asthma but were confined to eosinophilic or allergic phenotypes, leaving patients outside those groups without options. Tezspire (tezepelumab) removed the phenotype requirement.

Tezepelumab is the first biologic to block thymic stromal lymphopoietin, an epithelial alarmin upstream of multiple inflammatory cascades, which is why its label carries no phenotype or biomarker limitation. The subcutaneous injection is given every four weeks as add-on maintenance therapy for severe asthma in patients 12 years and older.

That unrestricted label is Tezspire’s core commercial advantage over IL-5 and IL-4/13-targeted competitors, and it faces no biosimilar competition. Expansion into other TSLP-driven airway diseases is the key catalyst to follow.

Approval Date
17-Dec-21
Data Exclusivity Expiry
17-Dec-25
Market Exclusivity Expiry
17-Dec-33
Commercial snapshot

Market performance & projections

Revenue ($M)
2,609
CAGR (%)
22.22%
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
3,722
2027
4,548
2028
5,256
2029
5,822
2030
6,415
2031
6,996
2032
7,494
Molecule profile

Details & specifications

Molecule
Tezepelumab-Ekko
Innovator
AMGEN INC
Dosage Form
Subcutaneous Solution
Strength
210 mg/1.91 mL (110 mg/mL)
Therapeutic Category
Respiratory agents
Usage
To treat severe asthma as an add-on maintenance therapy
Good to know

Frequently asked questions

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