After the invention of the drug, the company receives a registration certificate, and also has the exclusive right to manufacture and sell for 20 years. After this period, other pharmaceutical companies may produce analogues (or generics) of this drug.
Generics contain in their composition the same active ingredient as the original drug. However, the effect on the body may vary. This is due to several factors:
the raw materials for the production of a generic may differ greatly from the raw materials used for the original preparation – in terms of the degree of purification, extraction, etc. In other words, any pharmacological substance contains a certain proportion of impurities: the effect of the finished drug depends on their quantity, quality and production conditions;
excipients can be different.
They are present in the composition of any medicine to give shape to a tablet, capsule or ointment, to provide rapid solubility or prolong the effect;
the conditions for the production of medicines and the culture of labor organization may differ depending on the country of origin.
Analogues, of course, are also being tested: a pharmaceutical company that produces a generic drug must prove that it is bioequivalent to the original, that is, the indicators of movement in the body of the “replica” correspond to the original: at what speed the drug is absorbed, what maximum concentration the active substance reaches in the blood and how quickly it is excreted from the body.
At the same time, the law does not impose requirements for the verification of therapeutic equivalence to the original drug – key indicators of safety and effectiveness, so it is not always checked. Although it is precisely the therapeutic equivalence that determines the therapeutic effect similar to the original drug, as well as the possible presence of individual reactions.
It is always worth remembering that the low price of an analogue is explained by the fact that the company did not spend money on its invention and clinical research, and if, moreover, the manufacturer of the copy manages to buy raw materials cheaply, then it will be possible to sell the medicine at a low price. Therefore, you have an option: buy the original drug Hofitol ® or trust an analog. By the way, all stages of production of the drug Hofitol ® – from the purchase of raw materials to the final quality control – are located in France. This information is easy to check on the website of the Ministry of Health of the Russian Federation (www.grls.rosminzdrav.ru ).
Generics based on artichoke leaf extract, as a rule, cannot claim to have the same therapeutic efficacy and safety as the original drug.
Medicines and generics have been sorted out.