guselkumab
Marketed as TREMFYA.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| BLA761061 | TREMFYA | 2017-07-13 | JANSSEN BIOTECH |
Manufacturers
JANSSEN BIOTECH
Common denial patterns
- Step therapy requiring adalimumab biosimilar before IL-23
- Step therapy requiring ustekinumab first
- Prior auth missing PASI 75 failure documentation on prior biologic
- Indication restriction (psoriasis only, denying PsA or UC use)
Specific notes
Brand: Tremfya. Selective IL-23 (p19) inhibitor. FDA-approved for plaque psoriasis, PsA, and added ulcerative colitis indication September 2024. First IL-23 with UC approval.
Janssen CarePath: https://www.janssencarepath.com/patient/tremfya
Frequently asked questions
Why does insurance commonly deny guselkumab?
Step therapy requiring adalimumab biosimilar before IL-23; Step therapy requiring ustekinumab first; Prior auth missing PASI 75 failure documentation on prior biologic; Indication restriction (psoriasis only, denying PsA or UC use).
When was guselkumab FDA approved?
Earliest FDA approval on record: 2017-07-13.
What brand names are sold as guselkumab?
TREMFYA.
Is there a patient assistance program for guselkumab?
Yes — Janssen CarePath at https://www.janssencarepath.com/patient/tremfya.
What's specific to guselkumab?
Brand: Tremfya. Selective IL-23 (p19) inhibitor. FDA-approved for plaque psoriasis, PsA, and added ulcerative colitis indication September 2024. First IL-23 with UC approval.
Related
Sources
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