How are biosimilars
developed?

The science of biosimilars

Creating biosimilars in living cells takes a great deal of expertise and sophisticated technology. Here is why.

Biologics

Biological medicines or biologics is the umbrella term for different substances, which are manufactured using biotechnological processes. Those subtances that are used in the reference products are the basis for the development of biosimilar medicines.

Reference product vs. biosimilar

The biosimilar matches the reference medicine regarding structure, function, efficacy, and safety - it works in the same way as the reference product.

Small differences between the biosimilar and the reference product are allowed to occur but do not affect critical quality attributes.

A well-controlled manufacturing process ensures that the biosimilar product consistently matches the quality attributes of the reference medicine.

Clinical development

The development process of biosimilars can be split into four main phases:

Analytical phase

Preclinical phase

First clinical phase

Confirmatory clinical phase

How do biosimilars work?

Biosimilars work inside the body by supplementing or interrupting natural pathways, processes, and signals. This enables them to treat a specific disorder or disease.

Discover biosimilar medicines

The European Medicines Agency (EMA) provides further information about biosimilar medicines, their safety, and efficacy. Find out more by visiting their website, or by watching a video about biosimilars in the European Union.

Visit EMA website Watch the EMA video

How are biosimilarsdeveloped?