FDA — authorised 11 October 2012
- Application: BLA125276
- Marketing authorisation holder: GENENTECH
- Indication: Efficacy
- Status: approved
🇺🇸 Roactemra in United States
FDA authorised Roactemra on 11 October 2012
Marketing authorisations
FDA — authorised 19 November 2018
- Application: BLA125472
- Marketing authorisation holder: GENENTECH
- Indication: Efficacy
- Status: approved
FDA — authorised 22 July 2024
- Application: BLA761354
- Marketing authorisation holder: BIOGEN MA
- Status: approved
FDA — authorised 24 January 2025
- Application: BLA761420
- Marketing authorisation holder: CELLTRION INC
- Status: approved
FDA — authorised 12 May 2025
- Application: BLA761275
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
The FDA approved Roactemra for its labeling indication on 12 May 2025. The marketing authorization was granted to Fresenius Kabi USA, the holder of the BLA761275 application. Roactemra was approved through the standard expedited pathway.
Roactemra 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 Roactemra approved in United States?
Yes. FDA authorised it on 11 October 2012; FDA authorised it on 19 November 2018; FDA authorised it on 22 July 2024.
Who is the marketing authorisation holder for Roactemra in United States?
GENENTECH holds the US marketing authorisation.