Generics (single: generic) are copies of medicinal products that are the same as active ingredients (copycat drugs) and are already on the market and their patent protection has expired.
Newly developed drugs have been protected by patents for twenty years. During this time, the pharmaceutical company may sell its original product exclusively and determine its price. The manufacturer tries to recoup the high costs for researching and developing the new active substance. However, manufacturers usually register the patent for a new active ingredient when it is still in development. As soon as it comes on the market, part of the twenty years is over.
After patent protection has expired, the manufacturer of the original product must publish his research results on the active substance in question. Other manufacturers can then also use this information to produce the active ingredient and market it as a generic.
In the meantime, there is one or more generic drugs for almost every drug whose patent protection has expired. This applies to both over-the-counter products such as light headache medications and prescription medications such as preparations for high blood pressure, weak kidneys, diabetes (diabetes) or even cancer.
Generic manufacturers must demonstrate to the regulatory authorities that a generic corresponds to the original in terms of quality and effectiveness. However, this does not have to be done in large clinical studies and toxicological investigations, but a so-called bioequivalence test is sufficient. Accordingly, the generic and original are considered bioequivalent – that is, therapeutically equivalent – if the human body absorbs the active ingredient from the generic approximately as quickly and in approximately the same amount as that from the original (bioavailability). The word "approximately" already shows that the legislator allows a certain range of fluctuation: it is between 80 and 125 percent. For example, only 90 percent or 115 percent of the active ingredient from the generic can be absorbed compared to that from the original. In practice, however, the deviation for most copycat drugs is only about five percent.
In many cases, this small deviation doesn't matter much. With some medications, however, it depends on the exact speed of action. In these cases, the authorities can narrow the tolerance range.
A tolerance range for bioequivalence is necessary because the rate and quantity of an active ingredient can vary slightly from person to person. Gender and age, for example, have an influence on this. Accordingly, the measurement results of the individual subjects in a bioequivalence test are often different.
Generics must have the same dosage form as the original. However, all preparations taken orally (i.e. via the mouth) are considered the same, for example. This means: If the original is a tablet, the generic can and may come onto the market as a capsule or dragee.
There may be differences between a generic and its original preparation in the auxiliary substances added (e.g. preservatives and colorants) and in the manufacturing process. The further development of the added auxiliaries and / or the manufacturing process can improve the imitation preparation in some respects. For example, it can be kept longer, can be dosed more easily, or can be better tolerated by some people than the original product.
In addition, by changing the preparation, the generic can become the sustained release version of the original: the active ingredient is not released quickly and in one go, as is the case here, but slowly and continuously. This ensures a constant active ingredient level. In such cases, however, the generic drug, like the original, must go through extensive clinical trials in humans before it is approved.
Generic suppliers develop their counterfeit medicinal products based on the research results of the original manufacturer. In principle, only the costs for the production or modification of the preparation are incurred (e.g. other auxiliaries). The original manufacturer has already borne the enormous costs for research and development of the active ingredient itself.
The approval of a generic drug is also much cheaper: Bioequivalence tests, as prescribed for generic drugs of Kamagra or Levitra, are less complex and much cheaper than the clinical studies that the original drug has to go through.
Overall, generics suppliers have to invest much less money in their product than the manufacturer of the original product. You can therefore offer it much cheaper.
In terms of pricing, a second factor is also crucial: as soon as the patent protection for an active ingredient has expired, several generics manufacturers usually try to successfully sell their counterfeit drugs. As in other industries, the same rule applies here: more competition – lower prices.