What are biosimilars?

Biosimilars are medicines that are manufactured based on an already approved biological medicine.
They are used to treat serious, long-term illnesses and are equivalent to the ‘original medicine’ in terms of efficacy, safety and quality.

How do different types of medicines differ?

There are three types of medicines:

• Chemically synthesised medicines: active ingredients are produced using pure chemistry.
• Herbal medicines: the active ingredient comes exclusively from one or more plants.
• Biological medicines (biologics): Active ingredients come from living systems, e.g. blood or cells, or are produced with the help of cells (biotechnology).

Examples of biological medicines include insulin, vaccines, antibodies and growth hormones.

Explanation of terms: originator, generic, biosimilar

• When a new medicine with a new active ingredient is approved, it is called an originator.
• In the case of chemically synthesised medicines, when a copy of the originator is approved, it is called a generic.
• In the case of biological medicines, such a copycat product is called a biosimilar.

Why is more detailed testing necessary for biosimilars?

In the case of chemically synthesised medicines, the active ingredient formulas are exactly the same.
In the case of biological medicines, the active ingredient is not exactly the same, but only similar to the original product.

This sometimes leads to the misconception that biosimilars may be less effective or less safe. This is not the case, because:

• A biosimilar may only be approved if it has been proven that there is no significant difference from the original in terms of quality, safety and efficacy.
• Manufacturing companies must submit extensive tests and studies: in the laboratory (analysis), in preliminary trials (preclinical) and in human studies (clinical).
• A biosimilar can only be approved after certain periods of time have elapsed since the original was approved.

EMA reference: https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview