Purple Book product · Interchangeable
Omlyclo
omalizumab-igec
At a glance
Mar 07, 2025
Approved
Interchangeable
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Mar 07, 2025
1 yr 3 mo ago
Today
Pharmaceutical detail
Strength
150MG/ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Pre-Filled Syringe
Center
CDER
License number
1996
Product number
002
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyBiosimilar of omalizumab (Xolair)
- 2003XolairReference 351(a)
omalizumab · Genentech, Inc.
- 2018XolairReference 351(a)
omalizumab · Genentech, Inc.
- 2018XolairReference 351(a)
omalizumab · Genentech, Inc.
- 2023XolairReference 351(a)
omalizumab · Genentech, Inc.
- 2023XolairReference 351(a)
omalizumab · Genentech, Inc.
- 2023XolairReference 351(a)
omalizumab · Genentech, Inc.
- 2023XolairReference 351(a)
omalizumab · Genentech, Inc.
- 2025OmlycloInterchangeable
omalizumab-igec · CELLTRION, Inc.
- 2025OmlycloInterchangeable
omalizumab-igec · CELLTRION, Inc.
Patent list (8)
| Patent | Expires | In | Source |
|---|---|---|---|
| 10,034,940 | Nov 04, 2025 | 7 mo ago | FDA |
| 11,078,294 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 11,987,637 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 8,574,869 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 10,017,732 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 10,676,710 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 10,829,732 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 12,030,959 | Jul 20, 2043 | in 17 yr 5 mo | FDA |
Taxonomy and ontology
11 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
