Generic drugs are imitations of brand-name drugs that contain the same active pharmaceutical ingredients in the same dosage and have the same or at least an interchangeable dosage form.

Generic drugs (translation into German: Generika) are drugs that have a composition of the active pharmaceutical ingredient that is qualitatively and quantitatively equivalent to the reference listed drug in an equivalent dosage form and whose bioequivalence or therapeutic equivalence with the corresponding reference listed drug has been verified by appropriate studies. In the case of biologics, the generic versions are called biosimilars, as drugs that are biotechnologically produced in different manufacturing processes can only be regarded as similar, but not identical.

The most important features of generic drugs:

• Similarity to the original: Generic drugs are developed in such a way that they are as similar as possible to the original product. They contain the same active pharmaceutical ingredients (German translation: Wirkstoffe) and have similar pharmacodynamic and pharmacokinetic properties.
• Bioequivalence: Generic drugs must be bioequivalent (German: bioäquivalent) to the original product. This means that they must have a similar bioavailability, and any variation must be within a specific range compared to the original.
• Clinical trials: In order to obtain marketing authorization, generic drugs undergo clinical trials to prove their bioequivalence or, in the case of biologics, their similarity and safety.
• Safety and quality: Generic drugs are also subject to strict quality and safety controls to ensure their effective and safe use.
• Price: Generic drugs are generally less expensive than original products, which can make it easier for patients around the world to access the therapies they need, which also leads to major cost savings for health insurance companies in Germany.

The process of developing and approving generic drugs is complex and requires detailed equivalence and safety analyses. Generic drugs are an important aspect of the pharmaceutical industry, as they promote competition in the market and thus lead to lower prices. According to the Pro Generika Association, in Germany, for example, generic drugs account for around 80% of the demand for medicines.

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