ADALIMUMAB

The PBAC recommended the listing of adalimumab (Amgevita HC®) in the forms and strengths of strengths of 20 mg in 0.2 mL, 40 mg in 0.4 mL, pre filled syringe (PFS) and 40 mg in 0.4 mL, 80 mg in 0.8 mL pre filled pen (PFP) under the same circumstances as the currently PBS listed reference biologic, Humira® and other brands of adalimumab. The PBAC’s recommendation for listing was based on, among other matters, its assessment that the cost effectiveness of Amgevita PFS and PFP would be acceptable if it were cost minimised to Humira PFS and PFP and all other biosimilar brands and formulations of adalimumab. The PBAC advised the equi effective doses to be 1 mg of Amgevita = 1 mg of Humira and all other biosimilar brands and formulations of adalimumab.

The PBAC advised that Amgevita HC 20 mg/0.2 mL and 40 mg/0.4 mL PFS, and 40 mg/0.4 mL and 80 mg/0.8 mL PFP should be treated as equivalant to Humira and other adalimumab brands in the same form and strengths for the purposes of substitution (i.e. ‘a’-flagged in the Schedule). The PBAC also advised that Amgevita HC 40 mg/0.4 mL PFS and PFP should be considered equivalent for substitution with adalimumab 40 mg/0.8 mL PFS and PFP, respectively. In addition, Amgevita HC 20 mg/0.2 mL PFS and PFP are considered equivalent to adalimumab 20 mg/0.4 mL PFS and PFP.

The PBAC noted and welcomed the input from the Australasian Society of Clinical Immunology and Allergy and individuals. The PBAC acknowledge the new strengths and forms of Amgevita would improve quality of life and financial burden to patients. and the healthcare system.