FDA — authorised 13 September 2019
- Application: BLA761058
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Indication: Labeling
- Status: approved
🇺🇸 Humira in United States
FDA authorised Humira on 13 September 2019
Marketing authorisations
FDA — authorised 18 July 2022
- Application: BLA761071
- Marketing authorisation holder: SANDOZ INC
- Indication: Efficacy
- Status: approved
FDA — authorised 15 August 2022
- Application: BLA761059
- Marketing authorisation holder: SAMSUNG BIOEPIS CO LTD
- Indication: Efficacy
- Status: approved
FDA — authorised 15 December 2023
- Application: BLA761154
- Marketing authorisation holder: MYLAN PHARMS INC
- Indication: Labeling
- Status: approved
Mylan Pharms Inc received marketing authorisation for Humira from the FDA on 15 December 2023. The application number for this approval is BLA761154. The approved indication for Humira is listed in the labelling.
FDA — authorised 30 April 2024
- Application: BLA761118
- Marketing authorisation holder: PFIZER INC
- Indication: Labeling
- Status: approved
Pfizer Inc. received marketing authorisation from the US FDA for Humira on 30 April 2024. The authorisation was granted under the standard expedited pathway. The approved indication for Humira is listed in the labelling.
Humira in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Humira approved in United States?
Yes. FDA authorised it on 13 September 2019; FDA authorised it on 18 July 2022; FDA authorised it on 15 August 2022.
Who is the marketing authorisation holder for Humira in United States?
BOEHRINGER INGELHEIM holds the US marketing authorisation.