MARKET ACCESS AND COMMERCIALISATION STRATEGIES FOR BIOSIMILARS IN COMPETITIVE AND CONSTRAINED HEALTHCARE SYSTEMS

Abstract

Although biologics account for only a small proportion of prescription volumes, they represent a disproportionately large share of pharmaceutical expenditure. In the United States, biologics accounted for approximately 2% of prescription volume but 37% of net drug spending,[69] while specialty medicines are projected to account for approximately 43% of global pharmaceutical spending by 2028, [70] creating substantial financial pressures on healthcare systems.[70] Biological medications proven to be very similar to FDA-approved reference biologics in terms of structure, function, safety and effectiveness (called biosimilars) represent a proven way to reduce costs and increase patient access to treatment. The penetration of the market, however, is far from even across jurisdictions, and this has nothing to do with the quality of the product; it is related to the policy environments in which the product exists.