FDA — authorised 30 August 2016
- Application: BLA761042
- Marketing authorisation holder: SANDOZ
- Local brand name: ERELZI
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Biosimilar in United States
FDA authorised Biosimilar on 30 August 2016
Marketing authorisation
Biosimilar in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Biosimilar approved in United States?
Yes. FDA authorised it on 30 August 2016.
Who is the marketing authorisation holder for Biosimilar in United States?
SANDOZ holds the US marketing authorisation.