10 reasons why generics are just as good as the original

Generic medicines are an essential building block of the healthcare system. They enable many people to have access to proven medicines - from painkillers to life-prolonging cancer drugs. Patients can trust that a generic medicine is just as safe and effective as the original one. Please read 10 good reasons for generic medicines:

1. Same active ingredient

To be approved, generic medicines must contain the same active ingredient as the original preparation. The manufacturers have to prove this. Every medicinal product that is available in Germany must apply for a marketing authorisation from the Federal Institute for Drugs and Medical Devices (BfArM) or the corresponding sister authority at EU level (European Medicines Agency, EMA) and undergo an extensive procedure. In the process, the quality, efficacy and safety of the active substance are strictly tested.

2. Same amount of active ingredient

A generic medicine always contains the same amount of active ingredient as the reference drug. Only the excipients required for production, the manufacturing process itself, the shape and colour of the medicine and the presentation of the packaging may differ.

3. Same bioequivalence

The active ingredient of a generic medicine is absorbed by the body just as quickly and in the same quantity - it is therefore interchangeable - i.e. it has the bioequivalence of the reference product. Manufacturers have to prove this in bioavailability studies, which are subject to strict standards. The European Medicines Agency (EMA), the central licensing authority of the European Union, issues a license that is valid in all EU countries. The safety and efficacy of the generic medicine are thus guaranteed.

4. Same dosage form

Generic medicines are offered in the identical form as the original. This ensures that the medicine can be absorbed by the body in the same way. So if the original is marketed as a tablet that is taken orally, it is the same with a substitute.

5. Equal quality requirements

Generic medicines are subject to the same quality and drug safety requirements as all other medicines. In Germany, the criteria for the manufacture of medicinal products and active ingredients are regulated in the ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV). This lists in detail, for example, binding requirements for hygiene, storage, testing and labelling.

6. Equal control of production by authorities

German and European regulations govern the authorisation and quality monitoring of medicinal products in detail. They place the highest demands on every pharmaceutical manufacturer with regard to approval requirements, production processes and quality controls.

ALL manufacturing steps and suppliers are controlled by pharmaceutical authorities and local supervisory authorities.

For generic medicines, as for other medicines, strict requirements apply in terms of efficacy, safety and pharmaceutical quality.

7. Equal controls on the part of manufacturers

In addition to the controls prescribed by the authorities, manufacturers of generic medicinal products check every step in the manufacturing process with self-imposed quality controls in order to guarantee the safety of their medicinal products in the long term. These are carried out by specially trained employees who are solely responsible for monitoring quality standards within the company. For example, the quality of each individual delivery of raw materials is thoroughly examined in the laboratory before it is processed. In this was, for example, possible impurities of added excipients or active ingredients can be detected at an early stage.

8. Additional proof of efficacy in studies

In addition to proving the safety and efficacy of the active ingredient produced, generic manufacturers must in some cases conduct their own studies in order to obtain marketing authorisation. An example of this is the development of a sustained-release version (slower release of the active ingredient) of a medicinal product as a generic. In this case, it must be proven in clinical trials with test persons that a continuous level of the active ingredient is achieved by taking the medicine.

9. Equal protection against counterfeiting

Germany has one of the safest distribution channels in the world. This is due to the safety regulations that apply to all medicinal products - generics and reference preparations.

In order to prevent counterfeits, generic drug manufacturers take a variety of measures. Continuous controls by authorities, but also self-imposed control mechanisms as well as the equipment with authenticity features are important mechanisms to prevent counterfeits.

For example, the appearance of pharmaceutical packaging is precisely defined. Manufacturers cannot easily change this. This facilitates control in subsequent parts of the distribution chain. Security features, such as holograms, also offer protection. Since 2019, all prescription medicines in the EU must also be equipped with a seal and an individual security code.

10. Interchangeability with the original

Generic medicines are identical to the original. Therefore, medicinal products containing the same active ingredient in the same pharmaceutical form and active strength can be interchanged. This applies not only to the original medicinal product with the same active ingredient, but also to generic medicinal products among themselves. Quality and efficacy are proven with the approval by a state - BfArM (Federal Institute for Drugs and Medical Devices) or European authority – EMA (European Medicines Agency).