FDA — authorised 17 October 2023
- Application: BLA761151
- Marketing authorisation holder: UCB INC
- Local brand name: BIMZELX
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Bimzelx in United States
FDA authorised Bimzelx on 17 October 2023
Marketing authorisations
FDA
- Status: approved
Bimzelx in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Bimzelx approved in United States?
Yes. FDA authorised it on 17 October 2023; FDA has authorised it.
Who is the marketing authorisation holder for Bimzelx in United States?
UCB INC holds the US marketing authorisation.