STELARA®
(ustekinumab)
Medical inquiries
This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.
STELARA® (ustekinumab)
Medical Information
Ustekinumab – An Unbranded Biologic of STELARA® (ustekinumab)
Last Updated: 04/16/2025
Summary
- In 2024, Janssen Biotech, Inc. submitted a supplemental biologics license application (sBLA) for STELARA®
for an unbranded presentation of ustekinumab.1 This prior approval supplement for Ustekinumab, an unbranded biologic of STELARA®, was approved by the U.S. Food and Drug Administration (FDA) on April 01, 2025.2 - An unbranded biologic is marketed under its approved biologics license application (BLA) without its brand name on its label. An unbranded biologic is considered by the FDA to be equivalent to its brand name biological product because it is the same product as the brand name biological product under the same BLA. There are no differences in strength, dosage form, route of administration, or presentation compared to its approved brand-name biologic.3
- Ustekinumab is identical in composition and produced from the same cell line and at the same manufacturing sites as STELARA. It is labeled for all currently approved STELARA indications and has the same safety and efficacy profile as branded STELARA.2,
4 - Ustekinumab is not a biosimilar.
- Ustekinumab for injection is supplied as individually packaged, single-dose prefilled syringes or single-dose vials:2
- For subcutaneous use:
- Prefilled syringes:
- 45 mg/0.5 mL (NDC 57894-440-01)
- 90 mg/mL (NDC 57894-441-01)
- Single-dose vial:
- 45 mg/0.5 mL (NDC 57894-440-03)
- For intravenous infusion
- Single-dose vial:
- 130 mg/26 mL (5 mg/mL) (NDC 57894-444-01)
- For subcutaneous use:
- There are no changes to the formulations of STELARA. STELARA (ustekinumab) for injection is as individually packaged, single-dose prefilled syringes or single-dose vials:4
- For subcutaneous use:
- Prefilled syringes:
- 45 mg/0.5 mL (NDC 57894-060-03)
- 90 mg/mL (NDC 57894-061-03)
- Single-dose vial:
- 45 mg/0.5 mL (NDC 57894-060-02)
- For intravenous infusion
- Single-dose vial:
- 130 mg/26 mL (5 mg/mL) (NDC 57894-054-27)
- For subcutaneous use:
- For more information regarding Ustekinumab, please refer to the full US Prescribing Information for Ustekinumab.2
References
| 1 | Food and Drug Administration: Drugs at FDA: FDA-Approved Drugs. In: Accessdata.fda.gov [Internet]. Silver Spring (MD): Food and Drug Administration. 2016- [cited 2025 April 09]. Available from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm |
| 2 | |
| 3 | |
| 4 |