[Biosimilars : Current state of the build up to series production].

When patents expire, usually after 10 years in Germany, generic medicines routinely enter the market in place of conventional medications leading to significant reductions in prices. Currently the first biologicals are approaching patent expiry. Because of the biochemical complexities truly identical imitators are unrealistic. On the other hand, there is high socioeconomic pressure towards reduced cost of biologicals. In response to this situation the European Medicines Agency (EMA) has released a highly differentiated guidance document for the approval process of biosimilars. Biosimilars, which are already reality in other areas have to remain within a narrow biochemical variability corridor and are subsequently required to show bioequivalence to the reference product in both efficacy and safety in at least one large clinical phase III trial. In addition, post-marketing surveillance programs are mandatory in order to identify potential low frequency safety issues. In contrast to the "intended copies" used in some third world countries without such rigorous clinical testing the EMA-approved biosimilars are expected to have almost identical efficacy and safety as the reference medications. It is not yet clear how the use of specific biosimilars can be tracked and how uncontrolled exchange can be avoided. Nevertheless, biosimilars in rheumatology are likely to be available in the near future.