FDA — authorised 1 June 2010
- Marketing authorisation holder: AMGEN
- Status: approved
🇺🇸 Prolia in United States
FDA authorised Prolia on 1 June 2010
Marketing authorisations
FDA — authorised 1 June 2010
- Application: BLA125320
- Marketing authorisation holder: AMGEN
- Local brand name: PROLIA
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 24 October 2024
- Application: BLA761362
- Marketing authorisation holder: SANDOZ INC
- Indication: Labeling
- Status: approved
Sandoz Inc received marketing authorisation for Prolia from the FDA on 24 October 2024. The application number for this approval is BLA761362. Prolia is approved for its labelling indication.
FDA — authorised 13 February 2025
- Application: BLA761392
- Marketing authorisation holder: SAMSUNG BIOEPIS CO LTD
- Local brand name: XBRYK
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
FDA — authorised 28 February 2025
- Application: BLA761404
- Marketing authorisation holder: CELLTRION INC
- Local brand name: STOBOCLO
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 March 2025
- Application: BLA761398
- Marketing authorisation holder: FRESENIUS KABI USA LLC
- Local brand name: BOMYNTRA
- Indication: INJECTION
- Status: approved
FDA — authorised 29 August 2025
- Application: BLA761444
- Marketing authorisation holder: SHANGHAI HENLIUS BIOTECH
- Local brand name: BILDYOS
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 September 2025
- Application: BLA761436
- Marketing authorisation holder: BIOCON BIOLOGICS INC
- Local brand name: BOSAYA
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 September 2025
- Application: BLA761439
- Marketing authorisation holder: HIKMA PHARMACEUTICALS USA INC
- Local brand name: XTRENBO
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 19 December 2025
- Application: BLA761457
- Marketing authorisation holder: AMNEAL PHARMS LLC
- Status: approved
FDA — authorised 19 December 2025
- Application: BLA761456
- Marketing authorisation holder: AMNEAL PHARMS LLC
- Status: approved
Prolia in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Prolia approved in United States?
Yes. FDA authorised it on 1 June 2010; FDA authorised it on 1 June 2010; FDA authorised it on 24 October 2024.
Who is the marketing authorisation holder for Prolia in United States?
AMGEN holds the US marketing authorisation.