FDA — authorised 1 December 2017
- Application: BLA761074
- Marketing authorisation holder: MYLAN GMBH
- Local brand name: OGIVRI
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Trastuzumab biosimilar in United States
FDA authorised Trastuzumab biosimilar on 1 December 2017
Marketing authorisation
Trastuzumab biosimilar in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Trastuzumab biosimilar approved in United States?
Yes. FDA authorised it on 1 December 2017.
Who is the marketing authorisation holder for Trastuzumab biosimilar in United States?
MYLAN GMBH holds the US marketing authorisation.