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Ethical and generic drugs

Łukasz S. Kaczmarek 

Pharmaceutical Research Institute, Rydygiera 8, Warsaw 01-793, Poland


Today 60% of prescriptions filled in Europe up to more than 80% in USA are for generic drugs. In Poland generics represent almost 85% of whole drug market. Nevertheless, a large section of the polish public (including physicians) consider generics to be not as effective as brand name drugs. However, generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name products. When a generic drug product is approved, it has met rigorous standards established by the EMA with respect to identity, strength, quality, purity, and potency. Moreover, the generic drug manufacturer must prove its drug is the same (bioequivalent) as the brand name drug. All generic manufacturing, packaging, and testing sites must pass the same quality standards (GMP) as those of brand name drugs, and the generic products must meet the same exacting specifications as brand name products. In fact, many generic drugs are made in the same manufacturing plants as brand name drug products. When it comes to price, there is a big difference between generic and brand name drugs. On average, the cost of a generic drug is often 80 to 85 percent lower than the brand name product. It is possible, because generic manufacturers are not required to repeat the costly clinical trials of new drugs and generally do not pay for costly advertising, marketing, and promotion. This creates competition in the market place, often resulting also in lower prices of the brand name drugs.


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Related papers

Presentation: Invited oral at IX Multidyscyplinarna Konferencja Nauki o Leku, by Łukasz S. Kaczmarek
See On-line Journal of IX Multidyscyplinarna Konferencja Nauki o Leku

Submitted: 2014-04-23 07:45
Revised:   2014-05-02 10:55