A biosimilar is a biological medicine that contains a version of the active substance of an original biological product authorized in the European Economic Area (EEA), or reference product, to which it has been shown to be equivalent in quality, biological activity, efficacy and safety. through extensive comparative studies, according to the definition of the European Medicines Agency (EMA).
In this way, the biosimilar is authorized for all or some of the indications approved for the original reference medicinal product, and both products share the same dosage and route of administration.
In addition, the biosimilar is subjected to comparative studies to demonstrate that the slight physicochemical differences between the biosimilar candidate and the reference product have no clinical relevance. Physicochemical differences can also be detected between two batches of the same biological product, original or not, when they undergo changes in the manufacturing process.
This extensive battery of studies, also known as “comparability exercise” It allows us to maintain that the active principle of the biosimilar medicine and the original biologic are “in essence” the same.
In conclusion, a biosimilar is one more biological product whose particularity lies in the fact that it is a drug equivalent to an original biologic whose patent has expired, and with which it essentially shares the same active principle. Its advantage resides fundamentally in the competition caused by its launch on the market, which generally results in lower prices from which, ultimately, patients are the beneficiaries.