(freely translated from a text in English)
What is a biological drug?
A biological drug is a medicine containing an active substance produced by or from a living organism. Insulin, for example, is in effect a biological drug, as it is currently synthesized by a living organism (like a fungus or a bacterium), which thanks to genetic recombination techniques expresses the DNA necessary for the synthesis of this hormone.
What is a biosimilar drug?
A biosimilar drug is a medicine containing an active ingredient very similar to that characterizing a biological drug already authorized to trade by the competent institutes in the field. For this reason, in general, the two drugs are used at the same doses to treat the same disease. The ingredients are similar, if not identical, as is the name of the active ingredient.
Despite all these similarities, the decision to take one or the other drug is solely and exclusively up to the doctor; in fact there may be some slightly different indications and side effects, which make it more appropriate to use one drug than the other.
On what criteria is the marketing authorization for a biosimilar drug based?
Like all medicines, biosimilar medicines also require marketing authorization before they are available for purchase. This authorization is issued by a competing body, such as the EMEA, subject to evaluation of a series of studies concerning the efficacy, safety and quality of the drug.
Innovative drugs are protected from competition for a certain period of time. After this period of time, other pharmaceutical companies can acquire the marketing authorization for biosimilar drugs.
How is a biosimilar drug evaluated?
Given that at the time when biosimilars can be marketed the reference biological medicine has already been used for several years, there is an important amount of studies and information in this regard. There is therefore no need for a further and so long evaluation procedure, even if the legislature in this matter requires a series of studies that unequivocally demonstrate the absence of significant differences regarding efficacy and safety in use. Furthermore, if the therapeutic indications are different, the efficacy and safety of use of the biosimilar drug must also be demonstrated with reference to the new disorder or disease that is intended to be treated.
In addition to these rigorous studies, the competent bodies in the field require that the biosimilar drug be produced respecting the same quality standards as for all other medicines. Obviously also in this sense there is no lack of accurate and periodic checks on compliance with the laws in force on the subject.
How is the safety of a biosimilar drug monitored?
The safety of all drugs, including similar ones, continues to be carefully monitored even after authorization to trade. The law, in particular, requires that every pharmaceutical company has a system for monitoring the safety of the new drugs sold, including any immunological response (possible allergic phenomena). Obviously, even in this case, the competent bodies check that this monitoring system complies with the standards required by current legislation.
