Generic drug

A generic drug (plural generics) or imitation drug is a drug that has the same active ingredient as a previously approved drug. The generic product may differ from the original product in terms of the excipients it contains and the manufacturing technology. It is subject to a simplified marketing authorization, for which documents of the original drug are used, and is only produced after the patent protection of the original drug has expired. The name of a generic drug is usually composed of the generic name (INN) of the active ingredient and that of the marketing pharmaceutical company, but there are also generics with their own brand names (branded generics).

A generic product should be therapeutically equivalent to the original product in its claimed indications, i.e. it must correspond to it in efficacy and safety. This therapeutic equivalence is assumed for low molecular weight active ingredients if the statistical confidence interval of the bioavailability of a generic product lies within 80% to 125% of the bioavailability of the original product (bioequivalence). In practice, the deviation from the originator product is usually less than 5 %.

The regulations for therapeutic equivalence of biological drugs are still under discussion. Mostly, clinical studies in patients are still required to prove therapeutic equivalence (see biosimilars).

Cost

Generics are usually cheaper than the drug of the initial supplier, since no research costs are incurred and the development costs for a generic drug are comparatively low. In a study conducted in September 2004, Stiftung Warentest found that the prices for generic drugs are sometimes only a third of the original drug. The Techniker Krankenkasse found even higher differences in 2014 in an inventory market report examining the costs and benefits of some drugs. In the price comparison between original preparations and generics of frequently prescribed rheumatism preparations, the original preparations were up to 20 times more expensive than comparable generics, medications against diabetes mellitus were up to a factor of 18. In order to save costs, the statutory health insurances, supported by the German Act on the Economic Efficiency of Pharmaceutical Care (Arzneimittelversorgungs-Wirtschaftlichkeitsgesetz, AVWG), started in 2007 to force pharmacies, with the help of discount contracts with pharmaceutical manufacturers, to hand out only particularly low-priced preparations against a health insurance prescription, irrespective of the doctor's prescription. In the case of existing rebate contracts, the pharmacist must therefore, in accordance with the health insurance fund, dispense another drug with the same active ingredient instead of the original drug prescribed by name (except for any existing aut idem regulation), which is very often a generic drug.

In order not to immediately lose the benefits achieved through pharmaceutical research to generic drug manufacturers, the products developed by the research-based drug manufacturers (organized in Germany in the Association of Research-Based Pharmaceutical Companies) are protected by patents. The patent protection means that the original preparations have no competition from generics in the first few years after market launch. However, it also hinders the use of cheap new drugs in developing countries.

Example

Acetylsalicylic acid-containing preparations are among the oldest and best-known generics. The active ingredient, originally developed by Bayer AG in Leverkusen and marketed in various drug formulations under the name Aspirin, is now a component of numerous generics such as ASS Ratiopharm.