First EU biogenerics "possible in 2006, but USA faces long and winding road:" study

The first generation of biogeneric medicines - also known as biosimilars or follow-on protein products - could arrive on the market in the European Union as soon as this year, but they are unlikely to receive marketing approval in the USA before 2009, according to a new report from market analyst Datamonitor. All the same, the authors believe that these products are destined to become the next big battleground between branded pharmaceutical makers and the generics industry.

Biological therapeutic products such as epoetin are currently enormous money-spinners for the branded pharmaceutical majors, so it is hardly surprising that generics manufacturers are also keen for a slice of the action. However, the lack of a regulatory pathway in the USA has, thus far, led to the US Food and Drug Administration refusing to grant marketing approval for Omnitrope, the recombinant growth hormone made by Sandoz, the generics subsidiary of Swiss drugmaker Novartis. The agency told the firm that it had failed to reach a decision on Omnitrope because of uncertainties relating to scientific and legal issues (Marketletter September 13, 2004).

While there have also been problems relating to these products' approval within the European Union, regulatory authorities there are currently making genuine progress towards enabling a first generation of biogenerics, says Datamonitor. The study estimates that biologic products with combined global turnover totaling $20.00 billion in 2004 are currently at risk of facing this type of competition. However, it also points out that the nature of biologics virtually rules out the possibility of exact generic copies, and that this simple fact introduces an entire new level of complexity and expense into every stage of biogeneric development and commercialization.