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
As a first step, the quality profile of the reference product needs to be analysed in detail, in order to establish a highly similar profile of the biosimilar.
Preclinical phase
In the next phase, functional in-vitro-studies need to confirm the biological function and pharmacological effect.
First clinical phase
Studies involving healthy volunteers are conducted to determine that levels of the biosimilar and the reference product in the blood are equivalent.
Confirmatory clinical phase
A confirmatory study needs to be carried out to show the safety and efficacy of the biosimilar medicine.
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.