What are generic drugs?

Generic drugs are medicines that contain the same active ingredient as an already approved original medicine. They work in exactly the same way, but often have a different name and are usually cheaper.

For a drug to be considered a generic drug, it must:

• contain the same active ingredient in the same amount,
• have the same form (e.g. tablet, syrup, suppository),
• and have the same effect in the body as the original drug.

The original drug to which the generic drug refers is called the reference drug or originator.

How is a generic drug approved?

A generic drug may only be sold if:

• the original drug has been approved in the EU for at least ten years,
• and the generic drug has been shown in a special study to have the same effect as the original.

This study is called a bioequivalence study.

What is a bioequivalence study?

This study examines whether:

• the active ingredient in the generic drug enters the bloodstream just as quickly and in the same quantity as in the original drug.
• If the results show that the effect in the body is almost identical, the generic drug is considered equivalent. The study must meet certain requirements that apply throughout Europe.

Are there any differences between the original and the generic drug?

Yes, but only in certain respects:

• Excipients (e.g. fillers or colourings) may differ if they do not affect the effect.
• The manufacturing process may be different.
• The form may differ – e.g. tablet instead of capsule.

Important: The quality must be equally high for both. The generic drug must submit all documentation relating to its manufacture and quality – just like the original.

When can a generic drug be sold?

A generic drug is only approved if:

• the bioequivalence study is within the permitted limits,
• the safety is just as good as the original,
• the excipients and manufacturing have no influence on the effect,
• all legal requirements are met (e.g. package insert, packaging, information for doctors and patients).

Only then may the generic drug be placed on the market. This means that doctors and patients can be sure that approved generic drugs are reliable and safe.