FDA — authorised 28 November 2018
- Application: BLA761088
- Marketing authorisation holder: CELLTRION INC
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
🇺🇸 Mabthera in United States
FDA authorised Mabthera on 28 November 2018
Marketing authorisations
FDA — authorised 17 December 2020
- Application: BLA761140
- Marketing authorisation holder: AMGEN INC
- Status: approved
FDA — authorised 10 June 2021
- Application: BLA761064
- Marketing authorisation holder: GENENTECH INC
- Indication: Labeling
- Status: approved
FDA — authorised 30 June 2021
- Application: BLA103705
- Marketing authorisation holder: GENENTECH
- Indication: Labeling
- Status: approved
FDA — authorised 9 June 2025
- Application: BLA761103
- Marketing authorisation holder: PFIZER INC
- Status: approved
Mabthera 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 Mabthera approved in United States?
Yes. FDA authorised it on 28 November 2018; FDA authorised it on 17 December 2020; FDA authorised it on 10 June 2021.
Who is the marketing authorisation holder for Mabthera in United States?
CELLTRION INC holds the US marketing authorisation.