Generics, exactly like the so-called “biosimilars”, are subject to the same quality and efficacy requirements as the preparations of the original manufacturers. During the approval process in Germany, the quality and efficacy of the medicine is extensively analysed and tested. Upon successful completion of the analysis and testing, the competent authority grants a seal of approval. In Germany, the responsible authority for authorising and monitoring medicines is the Federal Institute for Drugs and Medical Devices (BFARM). For Europe, it is the European Medicines Agency (EMA) that grants pharmaceutical product marketing authorisations that are valid in all countries of the EU.