Introduction: As the number of biosimilar approvals in Australia increases, it will be important to establish a fast track regulatory framework to bring high quality, safe and efficacious biosimilars to the widest number of patients most cost-effectively. Before establishing a new regulatory framework, it is essential to understand how biologics and biosimilars are approved and regulated. The Alliance for Safe Biologic Medicines (ASBM) has asked prescribers of biosimilars in Australia for their opinions on how biosimilars are used and how they should be regulated. Currently, biologics and biosimilars are approved by Australia’s Therapeutic Goods Administration (TGA). The country’s Pharmaceutical Benefits Advisory Committee (PBAC) has indicated it will consider pharmacy level substitution of biosimilars for reference biologic medicines on a ‘case by case basis’.
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