Purple Book product · Biosimilar 351(k)
Avtozma
tocilizumab-anoh
At a glance
Jan 24, 2025
Approved
Biosimilar 351(k)
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Jan 24, 2025
1 yr 5 mo ago
Today
Pharmaceutical detail
Strength
162MG/0.9ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Autoinjector
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 tocilizumab (Actemra)
- 2010ActemraReference 351(a)
tocilizumab · Genentech, Inc.
- 2013ActemraReference 351(a)
tocilizumab · Genentech, Inc.
- 2010ActemraReference 351(a)
tocilizumab · Genentech, Inc.
- 2018ActemraReference 351(a)
tocilizumab · Genentech, Inc.
- 2010ActemraReference 351(a)
tocilizumab · Genentech, Inc.
- 2025AvtozmaInterchangeable
tocilizumab-anoh · CELLTRION, Inc.
Patent list (35)
| Patent | Expires | In | Source |
|---|---|---|---|
| 7,332,289 | Aug 04, 2023 | 2 yr 11 mo ago | FDA |
| 10,744,201 | Apr 28, 2024 | 2 yr 2 mo ago | FDA |
| 7,521,052 | Apr 28, 2024 | 2 yr 2 mo ago | FDA |
| 8,709,409 | Jun 22, 2024 | 2 yr ago | FDA |
| 8,734,800 | Mar 24, 2025 | 1 yr 3 mo ago | FDA |
| 9,902,777 | May 28, 2025 | 1 yr ago | FDA |
| 8,617,550 | Mar 03, 2026 | 3 mo ago | FDA |
| 8,398,980 | Feb 25, 2028 | in 1 yr 9 mo | FDA |
| 11,078,294 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 8,574,869 | Jul 08, 2028 | in 2 yr 2 mo | FDA |
| 11,008,394 | Dec 26, 2028 | in 2 yr 7 mo | FDA |
| 11,359,026 | Dec 26, 2028 | in 2 yr 7 mo | FDA |
| 11,584,798 | Dec 26, 2028 | in 2 yr 7 mo | FDA |
| 11,136,375 | Jul 19, 2029 | in 3 yr 2 mo | FDA |
| 8,568,720 | Nov 05, 2029 | in 3 yr 6 mo | FDA |
| 10,982,003 | Aug 06, 2030 | in 4 yr 3 mo | FDA |
| 9,714,293 | Aug 06, 2030 | in 4 yr 3 mo | FDA |
| 10,501,769 | Oct 25, 2030 | in 4 yr 5 mo | FDA |
| 11,021,728 | Oct 25, 2030 | in 4 yr 5 mo | FDA |
| 11,136,610 | Oct 25, 2030 | in 4 yr 5 mo | FDA |
| 11,377,678 | Oct 25, 2030 | in 4 yr 5 mo | FDA |
| 8,512,983 | Jan 04, 2031 | in 4 yr 8 mo | FDA |
| 10,662,237 | Aug 07, 2031 | in 5 yr 3 mo | FDA |
| 11,667,720 | Nov 07, 2031 | in 5 yr 6 mo | FDA |
| 8,580,264 | Nov 07, 2031 | in 5 yr 6 mo | FDA |
| 10,231,981 | Dec 03, 2031 | in 5 yr 7 mo | FDA |
| 10,874,677 | Mar 02, 2032 | in 5 yr 10 mo | FDA |
| 9,539,263 | May 23, 2032 | in 6 yr 1 mo | FDA |
| 9,750,752 | Aug 30, 2032 | in 6 yr 4 mo | FDA |
| 10,590,164 | Mar 19, 2033 | in 6 yr 11 mo | FDA |
| 9,630,988 | Jun 13, 2033 | in 7 yr 2 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 |
| 10,017,732 | Dec 25, 2034 | in 8 yr 8 mo | FDA |
| 10,336,983 | Jul 31, 2035 | in 9 yr 3 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) Biosimilar
blaType · 351(k) Biosimilar
application pathway
Section 351(k) Biosimilar or Interchangeable
blaType · 351(k)
product role
Biosimilar
blaType · Biosimilar
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
