Fresenius Kabi has walked away from the Australian adalimumab market and cancelled its approvals for 40mg Idacio® pre-filled syringe and 40mg Idacio® pen products which were approved as biosimilars to AbbVie’s Humira®. The withdrawals are listed on the TGA Medicines Shortage Reports Database with effect from 1 August 2024, and cite “commercial reasons/commercial viability” as the reason for the discontinuations.
Fresenius Kabi’s Idacio® was approved in Australia in June 2020. There are 8 additional biosimilars to AbbVie’s Humira® approved in Australia: Amgen’s Amgevita® (20mg/0.4ml, 40mg/0.8ml, approved in November 2017, PBS listed in April 2021); Samsung Bioepis’ Hadlima® (40mg/0.4ml, 40mg/0.8 ml) approved in January 2018, PBS listed in April 2021), Sandoz’s Hyrimoz® (20mg/0.2ml, 40mg/0.4ml, 80mg/0.8ml, approved in March 2019, PBS listed in April 2021), Pfizer’s Abrilada® (20mg/0.4ml, 40mg/0.8ml, approved in March 2021, PBS listed in August 2024, Mylan’s Hulio® (20mg/0.4ml, 40mg/0.8ml, approved in May 2021, Mylan not proceeding to PBS listing), Celltrion’s Yuflyma® (40mg/0.4ml, 80mg/0.8ml, approved in March 2022, PBS listed in March 2023, and Cipla’s Adalicip®/Ciptunec® (40mg/0.4ml, 80mg/0.8ml, approved in September 2022, PBS listed in January 2024).
Fresenius Kabi defended three separate Australian patent revocation actions commenced by Samsung Bioepis against Fresenius Kabi adalimumab formulation patents, all of which were resolved, including in at least one instance, with Fresenius Kabi surrendering the patent and being ordered to pay Samsung Bioepis’ costs.