Generics, as well as so-called biosimilars, are subject to the same quality and efficacy requirements as the preparations of the first manufacturers. During the approval process in Germany, the quality and efficacy of the drug are thoroughly investigated and tested. Upon successful examination, the competent authority shall issue a seal of approval. In Germany, the Federal Institute for Drugs and Medical Devices (BFARM) is responsible for the authorization of medicinal products and drug safety. For Europe, the European Medicines Agency (EMA) grants authorizations which apply in all EU countries.
FACT: 75% of the drug requirements of the statutory health insurances are covered by generics.