To Get Full Access :

aBLA Filing Intelligence & Biosimilar Opportunity

Spevigo

Spesolimab-Sbzo
Immunomodulators
Intravenous Injectable

Generalized pustular psoriasis flares are rare, painful, and potentially life-threatening, and treatment relied on agents borrowed off-label from plaque psoriasis. Spevigo (spesolimab) was the first therapy approved for the flares themselves.

By blocking the IL-36 receptor, a pathway genetically implicated in the disease, it interrupts the cascade driving widespread pustule formation, with many patients clearing within a week of a single dose. The intravenous infusion treats generalized pustular psoriasis flares in adults.

Spevigo has since added subcutaneous dosing for ongoing flare prevention and expanded into pediatric patients, converting it from acute rescue therapy into chronic management. It holds orphan designation and remains the only approved GPP-specific agent.

Approval Date
01-Sep-22
Data Exclusivity Expiry
01-Sep-26
Market Exclusivity Expiry
01-Sep-34
Commercial snapshot

Market performance & projections

Revenue ($M)
NA
CAGR (%)
NA
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
6
2027
118
2028
361
2029
703
2030
978
2031
1,121
2032
1,117
Molecule profile

Details & specifications

Molecule
Spesolimab-Sbzo
Innovator
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
Dosage Form
Intravenous Injectable
Strength
900 mg
Therapeutic Category
Immunomodulators
Usage
To treat generalized pustular psoriasis flares
Good to know

Frequently asked questions

Ready to act on this opportunity?

Talk to Spring Bio Solution about sourcing, licensing, and filing support for this molecule.

Why Spring Bio Solution

Supported 1000+ clinical trials globally

Provides services across regulatory, legal & clinical research

Unmatched intelligence on batches, expiry, spacing, and historical data from innovators

Integrated CRO services as part of our offerings

Insights on global pricing for smarter clinical trial supply decisions

Global sourcing capability across US, EU, South Africa, Canada, Japan, Australia, New Zealand, Southeast Asia, and other key markets

Login With

For full access Sign-up / Sign-in using below Methods:

By continuing, you agree to our Terms & Conditions and Privacy Policy. You can review them anytime.

Are you sure want to logout from NCE Grid?