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Sandoz’s 80mg/0.8mL (100mg/mL) Biosimilar Adalimumab PBS-Listed

Mar 1, 2025

On 1 March 2025, Sandoz’s high-concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab) 100mg/mL (80 mg/0.8 mL injection, 0.8 mL pen) was PBS listed for all Humira® indications.

This follows PBS-listing of Hyrimoz® 100mg/mL (40 mg/0.4 mL injection, 2 x 0.4 mL pen) formulation in January 2025.  High concentration Hyrimoz® was first approved in Australia in May 2024 and was recommended by Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) in its July 2024 meeting.

There are a number of other high-concentration (100mg/mL) adalimumab biosimilars approved in Australia, including Samsung Bioepis’ Hadlima® (February 2023), Cipla/Alvotech’s Ciptunex®/Adalicip® (September 2022) and Celltrion’s Yuflyma® (March 2022).