Purple Book product · Interchangeable
Wezlana
ustekinumab-auub
At a glance
Oct 31, 2023
Approved
Interchangeable
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Oct 31, 2023
2 yr 8 mo ago
First interchangeable exclusivity ends
Window blocking subsequent interchangeable approvals for the reference product.
Apr 30, 2025
1 yr 1 mo ago
Today
Pharmaceutical detail
Strength
90MG/ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
1080
Product number
002
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of ustekinumab (Stelara)
- 2009StelaraReference 351(a)
ustekinumab · Janssen Biotech, Inc.
- 2016StelaraReference 351(a)
ustekinumab · Janssen Biotech, Inc.
- 2009StelaraReference 351(a)
ustekinumab · Janssen Biotech, Inc.
- 2009StelaraReference 351(a)
ustekinumab · Janssen Biotech, Inc.
- 2009StelaraReference 351(a)
ustekinumab · Janssen Biotech, Inc.
- 2023WezlanaInterchangeable
ustekinumab-auub · Amgen Inc.
- 2023WezlanaInterchangeable
ustekinumab-auub · Amgen Inc.
- 2024WezlanaBiosimilar 351(k)
ustekinumab-auub · Amgen Inc.
- 2024WezlanaBiosimilar 351(k)
ustekinumab-auub · Amgen Inc.
Patent list (12)
| Patent | Expires | In | Source |
|---|---|---|---|
| 6,902,734 | Sep 25, 2023 | 2 yr 9 mo ago | FDA |
| 6,902,734 | Sep 25, 2023 | 2 yr 9 mo ago | FDA |
| 8,852,889 | Jul 06, 2032 | in 6 yr 2 mo | FDA |
| 8,852,889 | Jul 06, 2032 | in 6 yr 2 mo | FDA |
| 9,475,858 | Jul 06, 2032 | in 6 yr 2 mo | FDA |
| 9,475,858 | Jul 06, 2032 | in 6 yr 2 mo | FDA |
| 9,217,168 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,217,168 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,663,810 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,663,810 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 10,961,307 | Sep 24, 2039 | in 13 yr 6 mo | FDA |
| 10,961,307 | Sep 24, 2039 | in 13 yr 6 mo | FDA |
Taxonomy and ontology
12 termscenter
Center for Drug Evaluation and Research
center · CDER
application pathway
Biologics License Application
blaNumber · BLA
license type
351(k) Interchangeable
blaType · 351(k) Interchangeable
application pathway
Section 351(k) Biosimilar or Interchangeable
blaType · 351(k)
product role
Interchangeable Biologic
blaType · Interchangeable
marketing status
Prescription
marketingStatus · Rx
licensure status
Licensed
licensure · Licensed
route
Subcutaneous
routeOfAdministration · Subcutaneous
dosage form
Injection
dosageForm · Injection
source kind
Monthly Download
sourceKind · monthly_download
- Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
- Food and Drug Administrationsource forMonthly Download
- Biologics License Applicationparent ofSection 351(a) Biologic
- Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Biosimilar
- Section 351(k) Biosimilar or Interchangeablemaps to351(k) Interchangeable
Source provenance
