🇺🇸 sarilumab SAR153191 (REGN88) in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised sarilumab SAR153191 (REGN88) on 22 May 2017

Marketing authorisation

FDA — authorised 22 May 2017

Application: BLA761037
Marketing authorisation holder: SANOFI SYNTHELABO
Local brand name: KEVZARA
Indication: INJECTABLE — INJECTION
Status: approved

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Frequently asked questions

Is sarilumab SAR153191 (REGN88) approved in United States?

Yes. FDA authorised it on 22 May 2017.

Who is the marketing authorisation holder for sarilumab SAR153191 (REGN88) in United States?

SANOFI SYNTHELABO holds the US marketing authorisation.