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Potential New Biologics PBS Listings in September

Aug 19, 2024

A number of biopharmaceuticals and biosimilars are potentially in line for September listings on Australia’s Pharmaceutical Benefits Scheme (PBS).

UCB’s Bimzelx® (bimekizumab) has progressed to the last stage before PBS listing for psoriatic arthritis and ankylosing spondylitis (the drug is already subsidised for chronic plaque psoriasis). AstraZeneca and Daichii Sankyo are looking to expand Enhertu® (trastuzumab deruxtecan) for HER2-low unresectable or metastatic breast cancer.  Bimzelx® and Enhertu® were both recommended for listing on the PBS for these indications by Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) in April this year.

GSK’s Nucala (mepolizumab) may see its clinical criteria for the treatment of unresolved severe asthma amended to remove the oral corticosteroids requirement to bring it in line with current treatment guidelines.

As for biosimilars, there are possible changes to two biosimilars to Abbvie’s Humira® (adalimumab).  Following PBAC recommendations in March 2024, Organon may add a PBS-listing for a 40 mg in 0.4 ml PFP of Hadlima® (adalimumab-bwwd) and Celltrion may add 80 mg in 0.8 ml PFN and PFS of Yuflyma® (adalimumab-aaty).