Safety Issues of Biosimilar Products

Biosimilars are not expected to be direct copies of biologic medicines and are therefore not the same as generic drugs. Due to the complex structure of biologic medicines and the processes involved in production, biosimilars must be shown on the basis of analytical, non-clinical and clinical data to be similar to an original biologic in terms of structural characteristics, and safety and efficacy. Minor differences with the active ingredient are expected and permitted so long as any such differences are demonstrated not to be clinically meaningful. In 2012, 7% of worldwide sales (US $53 billion) were at risk as a result of the free entry of generic drugs, which compete directly with the original brands, forcing them to lower their prices or, even worse, to stop producing them. By 2020, it is expected that this loss of profitability will reach US $259 billion. This is clear that biosimilars impose some goods in terms of availability and affordability but surely a discourage to invention of newer biotech products in future.