A similar biological product and its corresponding reference medicine are equivalent and are administered by the same route, at the same dose and in the same, or less, indications, according to the criteria of the European Medicines Agency (EMA). The active substance of a biosimilar medicine is essentially the same as that of the original reference product with which equivalence has been demonstrated. The regulators themselves point out that the biosimilar that contains a version of the active principle of the original reference product, like two batches of the same original reference product, can contain two versions of an active principle.
The legislation of the European Union points out that each medicine is identified with a fancy name (brand), or by the name of the active substance next to the company name. The name of the active substance is the scientific name or DCI (International Nonproprietary Name – INN in English). It is sometimes known as a generic name. The DCI is proposed by the laboratory and agreed by the World Health Organization (WHO).
The name of a medicine is very important for clear identification and safe prescription and dispensing, and also for monitoring the safe use of medication throughout its entire life cycle. From a scientific point of view, since they essentially share the same active principle, the DCI of the biosimilar and the reference product is the same (unless, as in one case in Europe, the marketing laboratory proposes a change).
Similarly, it should be noted that the name of the active principle does not change in the reference biologics after a change in the manufacturing process. What's more, there are original biological medicines from different laboratories with the same name of the active ingredient, so the proposal to name the biosimilar and original reference with different DCI has no scientific support.
The first two biosimilar medicines approved in Europe have fancy names (Omnitrope and Valtropin), and both contain the same active ingredient, somatropin, same INN.
