On 1 September 2024, the PBS published its Summary of Changes, which included listing Pfizer’s Abrilada®, biosimilar to AbbVie’s Humira® (adalimumab), on the PBS in 40mg/0.8mL injections and 2 x 0.8 ml syringes.
This comes three years after Abrilada was first recommended for listing in July 2021 by Australia’s Pharmaceutical Benefits Advisory Council, with required documentation having not been submitted by Pfizer until February this year. Abrilada® was first approved by the TGA in March 2021 for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis.
There are 8 biosimilars to AbbVie’s Humira® approved in Australia: Amgen’s Amgevita® (approved in November 2017, PBS listed in April 2021); Samsung Bioepis’ Hadlima® (approved in January 2018, PBS listed in April 2021), Sandoz’s Hyrimoz® (approved in March 2019, PBS listed in April 2021), Pfizer’s Abrilada® (approved in March 2021, PBS listed in August 2024), Mylan’s Hulio® (approved in May 2021, Mylan not proceeding to PBS listing), Celltrion’s Yuflyma® (approved in March 2022, PBS listed in March 2023, and Cipla’s Adalicip®/Ciptunec® (approved in September 2022, PBS listed in January 2024).
In August 2024, Fresenius Kabi withdrew its adalimumab biosimilar, Idacio®, from the AU market citing “commercial reasons/commercial viability”.