At the PBAC meetings 6–8 July, Australia’s PBAC considered a number of applications for biologic and biosimilar products, including:
- Celltrion’s Yuflyma® (biosimilar adalimumab): requesting listing under the same conditions as Humira®;
- Pfizer’s Zirabev® (biosimilar bevacizumab): reviewing positive recommendations not accepted by Pfizer;
- Biogen’s Tysabri® (natalizumab): requesting removal of the clinical criterion which requires neurologists prescribing natalizumab under the PBS to be registered with the Tysabri Australian Prescribing Program;
- BMS’ Opdivo® (nivolumab): requesting a Section 100 Authority Required listing for adjuvant treatment of patients who have undergone radical resection of muscle invasive urothelial carcinoma originating in the bladder or upper urinary tract and are at high risk of recurrence;
- AbbVie’s Skyrizi® (risankizumab): requesting General Schedule Authority Required listings for the treatment of severe Crohn’s disease and for complex refractory fistulising Crohn’s disease;
- AstraZeneca’s Enhertu® (trastuzumab deruxtecan): requesting a Section 100 Authority Required listing for the treatment of human epidermal growth factor receptor 2 positive (HER2) metastatic breast cancer in patients whose disease has progressed following treatment with at least one prior HER2-directed regimen in the metastatic setting or whose disease has progressed during or within 6 months following HER2-directed adjuvant treatment; and
- Janssen’s Stelara® (ustekinumab): requesting a General Schedule Authority Required listing of a new form for the treatment of patients with Crohn’s disease and chronic plaque psoriasis.