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Frequently Asked Questions

We have collected below the most important and frequently asked question about our business. For further questions, please feel free to contact us and we will endeavor to address your question or comment to the best of our abilities and as quickly as possible.

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• Generic Medicines
• Generics Industry
• Biosimilars
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1. What are generics?

Generic medicines or "generics" are pharmaceuticals that contain the same active ingredients in the same concentration as the original medicine (reference product); they have the same dosage form and have demonstrated “bioequivalence” (see FAQ #13). Generics usually come to market after the data protection periods of the relevant reference products have expired.

2. What is the advantage of generics?

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.

3. Why am I suddenly hearing so much about generics?

Demand for medicines is increasing, driven by a steadily increasing life expectancy, economic growth, related lifestyle changes, technological progress and an aging population. Consequently, healthcare costs continue to rise year after year. Governments and health professionals are realizing the importance of promoting generics and acting accordingly.

4. Are generics safe?

Generic medicines have to be safe and effective to be approved by the FDA. The FDA also requires generic drug manufacturers to meet the same requirements for strength, purity, and quality as the original manufacturer and follow the same strict "Good Manufacturing Practices." (Source: GPhA)

5. Are generics the same as brand-name medicines?

Generics contain the same active ingredients in the same concentration in the same dosage form and their efficacy is verified by strict bioequivalence studies; in which they are directly compared with the respective reference product. 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 difference of significance is the lower price.

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