ustekinumab
Marketed as USTEKINUMAB.
FDA approval history
| FDA ID | Brand | Approval date | Manufacturer |
|---|---|---|---|
| BLA761044 | USTEKINUMAB | 2016-09-23 | JANSSEN BIOTECH |
| BLA125261 | USTEKINUMAB | 2009-09-25 | CENTOCOR ORTHO BIOTECH INC |
Manufacturers
JANSSEN BIOTECH, CENTOCOR ORTHO BIOTECH INC
Common denial patterns
- Step therapy requiring TNF-inhibitor first (plaque psoriasis, PsA, Crohn's, UC)
- Site-of-care reduction for IV induction dose
- Biosimilar substitution mid-treatment
- Prior auth missing PASI or HBI documentation
Specific notes
Brand: Stelara. IL-12/23 inhibitor. Loss of exclusivity 2023; FDA-approved biosimilars now include Wezlana (interchangeable), Selarsdi, Pyzchiva, Imuldosa, Otulfi, Steqeyma. Plans aggressively switching to biosimilar in 2025.
Janssen CarePath: https://www.janssencarepath.com/patient/stelara
Frequently asked questions
Why does insurance commonly deny ustekinumab?
Step therapy requiring TNF-inhibitor first (plaque psoriasis, PsA, Crohn's, UC); Site-of-care reduction for IV induction dose; Biosimilar substitution mid-treatment; Prior auth missing PASI or HBI documentation.
When was ustekinumab FDA approved?
Earliest FDA approval on record: 2009-09-25.
What brand names are sold as ustekinumab?
USTEKINUMAB.
Is there a patient assistance program for ustekinumab?
Yes — Janssen CarePath at https://www.janssencarepath.com/patient/stelara.
What's specific to ustekinumab?
Brand: Stelara. IL-12/23 inhibitor. Loss of exclusivity 2023; FDA-approved biosimilars now include Wezlana (interchangeable), Selarsdi, Pyzchiva, Imuldosa, Otulfi, Steqeyma. Plans aggressively switching to biosimilar in 2025.
Related
Sources
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