🇺🇸 Rituximab or biosimilar in United States

FDA authorised Rituximab or biosimilar on 17 December 2020

Marketing authorisation

FDA — authorised 17 December 2020

  • Application: BLA761140
  • Marketing authorisation holder: AMGEN INC
  • Local brand name: RIABNI
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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Frequently asked questions

Is Rituximab or biosimilar approved in United States?

Yes. FDA authorised it on 17 December 2020.

Who is the marketing authorisation holder for Rituximab or biosimilar in United States?

AMGEN INC holds the US marketing authorisation.