(freely translated from an English text)
What is a biological drug?
A biological drug is a medicine containing an active substance produced by or derived from a living organism. "Insulin, for example, is in effect a biological drug, as it is currently synthesized by a living organism (such as 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 drug containing an active ingredient very similar to that characterizing a biological drug already authorized on the market by the competent institutes on the subject. For this reason, in general, the two drugs are used at the same doses to treat the same disease. Similar, if not identical, are also the ingredients, as well as the name of the active ingredient.
Despite all these similarities, the decision to take one or the other drug rests solely and exclusively with the doctor; in fact, there may be slightly different indications and side effects, which make the use of one drug more suitable than the other.
What criteria is the marketing authorization of a biosimilar based on?
Like all medicines, before being available for purchase, biosimilar medicines also require a "marketing authorization". This authorization is issued by a competitive body, such as the EMEA, after evaluating a series of studies concerning the efficacy, safety and quality of the drug.
Innovative medicines enjoy, for a certain period of time, protection from competition. After this period of time, other pharmaceutical companies can acquire authorization for the marketing of biosimilar drugs.
How is a biosimilar drug evaluated?
Given that at the date on which biosimilar medicines can be marketed, the biological reference 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 such long evaluation process. , even if the legislature on the subject nevertheless requires a series of studies that unequivocally demonstrate the absence of significant differences regarding efficacy and safety of 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 to be treated.
In addition to these rigorous studies, the competent bodies on the subject require that the biosimilar drug be produced respecting the same quality standards as for all other medicines. Obviously, even 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 marketing authorization. The law, in particular, requires every pharmaceutical company to have a system for monitoring the safety of new drugs marketed, including any response. of an immunological nature (possible allergic phenomena) Obviously, even in this case the competent bodies check that this monitoring system complies with the standards required by current legislation.
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