PBS adds first ustekinumab and omalizumab biosimilars in inflammatory and allergic conditions

From 1 August 2025, two new biosimilars – SteQeyma (ustekinumab) and Omlyclo (omalizumab) – have been listed on the Pharmaceutical Benefits Scheme (PBS) for inflammatory and allergic conditions.

SteQeyma is now reimbursed for a range of chronic immune-mediated diseases, including Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis (PsA). Omlyclo is listed for allergic asthma and chronic spontaneous urticaria (CSU).

For Australian patients with Crohn’s disease and ulcerative colitis, this is the first PBS-listed biosimilar alternative to ustekinumab in over five years. Professor Rupert Leong, Gastroenterologist and IBD specialist in Sydney, said the listing addresses a long-standing need for cost-effective access to one of the most relied upon treatment options.

“Ustekinumab is an important therapeutic option for patients who have not responded to other treatments. In advanced treatment of Crohn’s disease and ulcerative colitis, ustekinumab is dispensed about 50 per cent of the time for Crohn’s disease as it tends to be a well maintained and durable form of therapy,” Professor Leong said.

“Combining its treatment profile with the reduced overall costs of a biosimilar and a price drop is something we’ve long been waiting for. Our patients are getting older and living longer with these diseases and we are needing to use treatments that are not associated with increased cancer or infection risks,” he added.

In terms of market dynamics, while OECD countries average 67% biosimilar uptake, Australia’s adoption rate for anti-TNF biosimilars is only around 36%.

The introduction of a biosimilar to the PBS triggers an automatic 25% price reduction for both the reference biologic and its biosimilar. However, unlike generic medicines where patients can benefit from lower out-of-pocket costs, PBS-listed biosimilars carry the same co-payment as the originator, removing any direct financial incentive for patients to choose a biosimilar.

Patient and clinician preference for original biologics remains a barrier to switching, particularly when the change is not clinically necessary. Common concerns include perceived inferiority, fear of adverse events, or satisfaction with current treatment. Yet, most patients are open to biosimilars – particularly in terms of new treatment initiation – if recommended by their specialist.

“Through the PBS we can help make a real difference in patient lives both from an economic and health benefit perspective,” said Heegun Kim, Country Manager of Celltrion Healthcare Australia.

“As the first and currently only ustekinumab and omalizumab biosimilars available on the PBS, SteQeyma and Omlyclo further offer significant work-flow reduction to doctors and other clinical staff managing the to-date lengthy application processes and administrative burden.”

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