FDA — authorised 17 September 2021
- Application: BLA761202
- Marketing authorisation holder: SAMSUNG BIOEPIS CO LTD
- Local brand name: BYOOVIZ
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 BYOOVIZ in United States
FDA authorised BYOOVIZ on 17 September 2021
Marketing authorisations
FDA
- Status: approved
BYOOVIZ in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is BYOOVIZ approved in United States?
Yes. FDA authorised it on 17 September 2021; FDA has authorised it.
Who is the marketing authorisation holder for BYOOVIZ in United States?
SAMSUNG BIOEPIS CO LTD holds the US marketing authorisation.