11^th European Biosimilars Congress

Biosimilars in Europe are typically branded differently from the reference drug, however the non-proprietary names of European biosimilars are identical to those of their reference drug. More specifically, biosimilars are named according to the degree of "similarity" if compared with the biologics. When the physico-chemical differences stay in the range defined by EMA, they take the same INN (International Nonproprietary Names) of biologics; when the range is exceeded, it is necessary to create a new INN. The situation is different in USA, where the FDA requires - for all biologic products – that a randomlygenerated suffix is added to the INN in all cases. This presentation is aimed at addressing the consequences of the different policies in Europe and USA with regard to the branding of biosimilars on the industry, and on the development of the market.