New legislation has recently come into effect in the UK allowing generic firms to gain marketing approval for their products before the patents on the original drugs have expired. This will allow them to launch generic versions in the European Union (EU) more rapidly.
However, research-based drug firms have criticised the move, saying that it will adversely affect revenues and limit their capacity to produce innovative drugs in the future. Industry observers claim that the generics industry is already receiving substantial government support, with generics penetration among the highest in Europe. In 2004, there was a generics prescribing rate in the UK of 80%, while sales of generics grew reached US$4.8bn, an increase of 26%.
Elsewhere, a recent industry study has claimed that generic versions of biotech drugs are still many years away from reaching the market in the Europe and the US. Industry sources claim that part of the problem lies in the fact that it is much harder to prove bio-equivalence for biotech drugs, due to the complicated and sophisticated nature of their structures.
Generic drugmakers are frustrated by the delays, as they had hoped to benefit from the expiry of patents on the first generation of biotech drugs. They claim that human growth hormone and insulin products should be covered under normal regulatory guidelines. The branded biotech market is worth US$30bn per year in the US alone.