“Bio” has its roots in the Greek language and means “life”; a biopharmaceutical is therefore a medicine that has been produced by living organisms or that has been derived from living organisms¹. These biopharmaceuticals are also called biologics. Biologics are complex medicines with heterogeneous structures produced during complex and technologically advanced manufacturing processes with the help of what is called recombinant technology^2,3.

Biosimilars are complex medicines made from living cells or organisms

The Biosimilar Medicines Group in Europe defines biosimilar medicines as versions of existing biopharmaceuticals, for which marketing exclusivity rights have expired, with proven comparable quality, efficacy, and safety to that of the originator reference medicinal products (in other words the originator biologic).¹ In the US, the Food & Drug Administration (FDA), defines a biosimilar as a biological product that is highly similar to the reference product, notwithstanding minor differences in clinically inactive components.² In other words, biosimilar medicines are highly similar in all essential aspects to an already approved biologic.^{3, 4}

From these definitions it can be seen that biosimilars are as effective and safe and of similar quality as the original product. One can therefore expect that, when using a biosimilar to treat a specific disease or condition, the clinical outcome will be similar to that obtained with the biologic. In fact, there are no clinically meaningful differences between the biosimilar product and the reference product in terms of safety, purity, and potency.^{2, 4}