Organon’s high concentration, citrate-free formulation of Humira biosimilar PBS listed

Pharma News: Organon Australia has announced the launch of its new high concentration, citrate-free formulation of Humira (adalimumab) biosimilar, Hadlima (adalimumab 40mg/0.4mL), in the management of autoimmune diseases.

The Hadlima high concentration formulation is a biosimilar to adalimumab, commonly used to treat various autoimmune conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.

Among the improvements to Hadlima high concentration formulation is the reduced injection volume, cutting it by 50% to 40mg/0.4mL. This means patients will inject less liquid, potentially improving comfort during administration.

Another notable change is the removal of citrate buffers, known for causing pain upon injection. Studies have shown that minimising injection-site pain is crucial for enhancing patient adherence to treatment plans. Furthermore, the new formulation allows for extended room temperature storage, increasing its shelf life at room temperature to 31 days, compared to 28 days in previous versions.

Professor Stephen Hall, a leading rheumatologist, said “As clinicians, we want to minimise patient discomfort and help them adhere to their treatment plan. The upcoming PBS listing of Hadlima (40mg/0.4mL) provides us with more citrate-free options for treatment using adalimumab.”

Since April 2021, Hadlima (40mg/0.8mL) has been available on the Pharmaceutical Benefits Scheme (PBS), offering patients, clinicians, and pharmacists a choice between autoinjector and pre-filled syringe drug delivery. The new presentation will also be available in these options and is set to be listed on the PBS from October 1.

Tim Cogin, Fertility and Biosimilars Director at Organon ANZ, echoed these sentiments, saying “We are excited to bring Hadlima (40mg/0.4mL) high concentration to the Australian market. This new formulation underscores our commitment to improving the lives of patients by offering another treatment option for patients.”

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