FDA Purple Book · Reference family
guselkumab (Tremfya)
guselkumab is an FDA-licensed reference biologic from Janssen Biotech, Inc.. 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
351(a)BLA 761061
Tremfya guselkumab
Janssen Biotech, Inc.
- Approved
- Mar 25, 2025
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for guselkumab, in chronological order.
Reference approval
Approval date of the reference guselkumab product.
1 yr 2 mo ago
Frequently asked questions
Are there biosimilars approved for guselkumab (Tremfya)?
No 351(k) biosimilars or interchangeable biosimilars referencing guselkumab are listed in the FDA Purple Book yet.
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