FAQ

General / market: * Generics are subject to different legal definitions in different countries. The definition of generics as used in this context does not make reference to any particular legal definition.

  • Generic medicines or "generics" are pharmaceuticals that contain the same active ingredients in the same concentration as the original - reference – medicine; they have the same dosage form and have demonstrated bioequivalence. Because they act in the same way in the human body, they are interchangeable with reference products. Generics usually come to market after the data protection periods of the relevant reference products have expired.07-12-2007
  • Generics offer the same efficacy as reference products at a significant discount. Lower prices make medicines available to people who might otherwise be unable to afford them. They also help to relieve financial pressure on increasingly cost-conscious public health systems.07-12-2007
  • Demand for medicines is increasing all the time, driven by a steadily aging global population, economic growth, related lifestyle changes and technological progress. At the same time, healthcare costs continue to rise year on year. Governments and health professionals worldwide are realizing the importance of promoting generics and are acting accordingly.07-12-2007
  • Medicines represent between 8% and 15% of total health spending. Developed countries are struggling to control rapidly rising healthcare costs, while people in developing countries are often unable to afford live-saving medicines. Generics increase access by keeping costs down, and may often help to save lives. In addition, savings can free up resources for new innovative medicines – which will in turn become the generics of the future.07-12-2007
  • Generics already have a greater overall market share than reference products in many countries. However, because they cost significantly less, their total cost is still much lower. For example (2005 figures): generics in the US accounted for 56% of total medicines sold, but only 13% of sales revenue. In Germany, they accounted for 51% of medicines sold, but only 29% of sales.07-12-2007
  • The generics industry worldwide is growing by roughly 10% per year on average, and this rate is expected to continue, with some regional variations. This is significantly higher than the equivalent growth rate for branded pharmaceuticals, so the trend is very clear.07-12-2007
  • Generics are offered at significantly lower prices than reference medicines because initial basic and clinical research programs do not need to be repeated in full, thus reducing investment. These cost savings are passed on to patients.07-12-2007
  • The savings are significant. Generics can cost anywhere from 20% to 90% less than the price of reference medicines. Furthermore, competition from generics forces reference product manufacturers to reduce their own prices after – or sometimes even before – patent expiry or expiry of the data protection period.07-12-2007
  • Yes. Generic medicines contain the same active ingredients and act in the same way in the human body. They may contain different non-active ingredients or differ in size, shape or color, but these differences have no impact on their therapeutic effect. The only significant difference to reference products is the price.07-12-2007
  • Generics contain the same active ingredients in the same concentration in the same dosage form and their efficacy is verified by strict bioequivalence studies. They may vary in their method of preparation or in the composition of inactive ingredients such as colorings or binders, which have no therapeutic effects. The only significant difference is the price.

    07-12-2007