Purple Book reference family · 351(a) biologic
guselkumab (Tremfya)
guselkumab is an FDA-licensed reference biologic from Janssen Biotech, Inc..
351(a) biologicBLA 761061 Janssen Biotech, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 761061
Tremfya guselkumab
Janssen Biotech, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference guselkumab product.
1 yr 4 mo ago
guselkumab: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for guselkumab.
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