Purple Book product · Interchangeable
Hadlima
adalimumab-bwwd
At a glance
Aug 15, 2022
Approved
Interchangeable
License type
Rx
Marketing
No
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Aug 15, 2022
3 yr 10 mo ago
Today
Pharmaceutical detail
Strength
40MG/0.4ML
Dosage form
Injection
Route
Subcutaneous
Presentation
Autoinjector
Center
CDER
License number
2046
Product number
004
Submission type
Supplement
Supplement number
5
Change type
Not listed
Reference product family
View full familyBiosimilar of adalimumab (Humira)
- 2002HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2002HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2008HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2013HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2014HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2015HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2016HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2016HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2017HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2017HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2017HumiraReference 351(a)
adalimumab · AbbVie Inc.
- 2019HadlimaInterchangeable
adalimumab-bwwd · Samsung Bioepis Co., Ltd.
Patent list (66)
| Patent | Expires | In | Source |
|---|---|---|---|
| 8,911,737 | Jun 05, 2022 | 4 yr 1 mo ago | FDA |
| 8,974,790 | Jun 05, 2022 | 4 yr 1 mo ago | FDA |
| 8,992,926 | Jun 05, 2022 | 4 yr 1 mo ago | FDA |
| 9,546,212 | Jun 05, 2022 | 4 yr 1 mo ago | FDA |
| 6,805,686 | May 06, 2023 | 3 yr 2 mo ago | FDA |
| 8,906,373 | Jul 18, 2023 | 2 yr 11 mo ago | FDA |
| 9,067,992 | Jul 18, 2023 | 2 yr 11 mo ago | FDA |
| 9,085,620 | Jul 18, 2023 | 2 yr 11 mo ago | FDA |
| 9,090,689 | Jul 18, 2023 | 2 yr 11 mo ago | FDA |
| 8,961,973 | Apr 11, 2025 | 1 yr 2 mo ago | FDA |
| 8,961,974 | Apr 11, 2025 | 1 yr 2 mo ago | FDA |
| 8,986,693 | Apr 11, 2025 | 1 yr 2 mo ago | FDA |
| 9,061,005 | Apr 11, 2025 | 1 yr 2 mo ago | FDA |
| 9,187,559 | Apr 11, 2025 | 1 yr 2 mo ago | FDA |
| 9,512,216 | Apr 11, 2025 | 1 yr 2 mo ago | FDA |
| 8,808,700 | May 16, 2026 | 19 d ago | FDA |
| 11,083,792 | Apr 04, 2027 | in 10 mo | FDA |
| 8,231,876 | Apr 04, 2027 | in 10 mo | FDA |
| 8,883,156 | Apr 04, 2027 | in 10 mo | FDA |
| 8,895,009 | Apr 04, 2027 | in 10 mo | FDA |
| 8,906,372 | Apr 04, 2027 | in 10 mo | FDA |
| 8,916,153 | Apr 04, 2027 | in 10 mo | FDA |
| 9,096,666 | Apr 04, 2027 | in 10 mo | FDA |
| 9,102,723 | Apr 04, 2027 | in 10 mo | FDA |
| 9,273,132 | Apr 04, 2027 | in 10 mo | FDA |
| 9,328,165 | Apr 04, 2027 | in 10 mo | FDA |
| 9,913,902 | Apr 04, 2027 | in 10 mo | FDA |
| 8,926,975 | Jun 08, 2027 | in 1 yr | FDA |
| 8,715,664 | Jul 24, 2027 | in 1 yr 2 mo | FDA |
| 8,663,945 | Sep 13, 2027 | in 1 yr 4 mo | FDA |
| 8,906,646 | Sep 13, 2027 | in 1 yr 4 mo | FDA |
| 8,911,964 | Sep 13, 2027 | in 1 yr 4 mo | FDA |
| 9,090,867 | Sep 13, 2027 | in 1 yr 4 mo | FDA |
| 9,234,032 | Sep 13, 2027 | in 1 yr 4 mo | FDA |
| 9,284,371 | Sep 13, 2027 | in 1 yr 4 mo | FDA |
| 8,889,136 | Oct 09, 2027 | in 1 yr 4 mo | FDA |
| 9,284,370 | Jun 10, 2028 | in 2 yr 1 mo | FDA |
| 9,669,093 | Jun 10, 2028 | in 2 yr 1 mo | FDA |
| 11,167,030 | Nov 28, 2028 | in 2 yr 6 mo | FDA |
| 11,191,834 | Nov 28, 2028 | in 2 yr 6 mo | FDA |
| 9,085,619 | Nov 28, 2028 | in 2 yr 6 mo | FDA |
| 8,420,081 | Jan 13, 2030 | in 3 yr 8 mo | FDA |
| 8,999,337 | Feb 06, 2031 | in 4 yr 9 mo | FDA |
| 9,624,295 | Mar 31, 2031 | in 4 yr 11 mo | FDA |
| 8,708,968 | Jan 24, 2032 | in 5 yr 9 mo | FDA |
| 9,339,610 | Jan 24, 2032 | in 5 yr 9 mo | FDA |
| 9,062,106 | Apr 26, 2032 | in 6 yr | FDA |
| 9,090,688 | Apr 26, 2032 | in 6 yr | FDA |
| 9,505,834 | Apr 26, 2032 | in 6 yr | FDA |
| 9,522,953 | Apr 26, 2032 | in 6 yr | FDA |
| 9,683,033 | Apr 26, 2032 | in 6 yr | FDA |
| 9,957,318 | Apr 26, 2032 | in 6 yr | FDA |
| 9,085,618 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,181,337 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,181,572 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,290,568 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,334,319 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,346,879 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,359,434 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,499,616 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,708,400 | Mar 14, 2033 | in 6 yr 11 mo | FDA |
| 9,315,574 | Apr 21, 2033 | in 7 yr | FDA |
| 9,150,645 | May 13, 2033 | in 7 yr 1 mo | FDA |
| 9,266,949 | May 13, 2033 | in 7 yr 1 mo | FDA |
| 9,499,614 | Mar 14, 2034 | in 7 yr 11 mo | FDA |
| 9,550,826 | Nov 14, 2034 | in 8 yr 7 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
