The biosimilar drugs could be classified as the great unknown. For some time now, there has been a lot of talk about them, but when people ask what a biosimilar is beyond specialized forums, silence usually reigns, or they tend to provide inaccurate arguments.

First of all, it should be made clear that biosimilars are biological medicines since they are obtained from living organisms, which distinguishes them from chemical synthesis medicines that do not require cells or animals for their production. As an example of biologics we can mention insulin, growth hormone or monoclonal antibodies.

Within biological medicines, a difference can be made between original biological medicines and biosimilar biological medicines. This is essentially a differentiation of a regulatory nature because it alludes to the studies necessary to establish the benefit/risk profile.

For a biosimilar can prove equivalent quality, efficacy and safety to an original biologic, the laboratory that develops the biosimilar is required to demonstrate that equivalence through a rigorous and exhaustive comparison procedure called “comparability exercise”.

The purpose of this exercise is to demonstrate that the slight structural differences existing between both products, inherent to their biological condition, and which can sometimes be detected between batches of original products, do not have an impact on quality, efficacy or safety, which is why It can be argued that the active principle of both is essentially the same.

In conclusion, we can say that A biosimilar is a biological medicine more that contains a version of the active principle of an original biological product to which it has been shown to be equivalent, which is why it offers the same therapeutic guarantees.