spesolimab-sbzo (Spevigo)
spesolimab-sbzo is an FDA-licensed reference biologic from LEO Pharma A/S. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2025
Reference approved
Reference product
Spevigo spesolimab-sbzo
LEO Pharma A/S
- Approved
- May 28, 2025
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for spesolimab-sbzo, in chronological order.
Reference approval
Approval date of the reference spesolimab-sbzo product.
1 yr ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 10 mo
Frequently asked questions
Are there biosimilars approved for spesolimab-sbzo (Spevigo)?
No 351(k) biosimilars or interchangeable biosimilars referencing spesolimab-sbzo are listed in the FDA Purple Book yet.
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