ABSTRACT
Commercialization of drugs takes a very different path between countries and more so between continents. The advent of "biosimilars" in the European Union has prompted development by generic drug suppliers vying to expand their market share, payers calculating significant savings, and physicians and pharmacists hoping improved treatment modalities. The total cost of using drugs is made by the addition of costs supported by the buyer and linked to administrative, logistical, and clinical protocol procedures, etc., implemented. There is a general misconception that the cost of pharmacovigilance and risk management plan is higher for biosimilars compared to other biological drugs, or that the buyers such as institutions are required to share this cost. Therapeutic Goods Administration is a division of the Australian Government Department of Health and Ageing and is responsible for regulating therapeutic goods, including medicines, medical devices, blood, and blood products, including biosimilars.
