How to buy drugs cheaper and at the same time have a guarantee that they are effective? Most Poles ask themselves this question. The issue of the so-called generic drugs that are substitutes for the original drug. We asked experts for their opinions on this matter.
Arecheaper counterpartsoriginal drugs, so-called generics, do they actually have the same effect and it's just about the difference in price? In the letter of the Polish Association of Pharmaceutical Industry Employers signed by Cezary Śledziewski, President of the Management Board, we read, among others:
"Pursuant to the law in force in the EU and in Poland, generic drugs are registered after the expiry of patent protection for the original drug, ie after about 20 years. Due to the development of the pharmaceutical industry, their production technology may be more modern than the original ones, and the difference in price is due to the fact that the same generic drug may be produced by many manufacturers who compete with the price on the market.
The producer of generic does not conduct clinical trials of the active substance, but must prove that the substance, tested and available on the market for 20 years, is absorbed in the body in the body in the case of its drug as in the original drug. The basis for the registration of generic are bioequivalence tests that check the degree and speed of absorption of the active substance. It is absorbed into the circulation not a tablet (different in the original and generic medicine), but only in the molecules of the active substance - registration of a generic consists in examining whether their absorption is the same as in the original drug.
Therefore, a generic drug cannot work worse or even better than the original drug. It must work the same. The cheaper counterpart - apart from the fact that it contains the same therapeutic substance, which must be absorbed in the same degree and time - has the same guarantees of effectiveness, quality and safety as the original drug. Its production is based on the same manufacturing standards.
No drug can be placed on the market in the EU without obtaining a positive opinion from one of the European medicines agencies. This is a guarantee for patients of the quality of pharmaceuticals, which applies equally to all drugs. "
So much for theory, but how is it in practice? Experts argue that it is impossible to put an equal sign betweengeneric and original. Although generic and original drugs contain the same active substance, they differ in the production technology and content of additional substances, which may affect the drug's effectiveness and its side effects.
GRZEGORZ BORSTERN, specialist in internal medicine:
I am not an opponentgeneric drugs.For many people, especially those chronically ill and constantly taking several preparations, the use of substitutes is the only chance for uninterrupted treatment. But you cannot equateoriginal drugandgeneric drugseven though they contain the same drug (active ingredient) in the same dose ( 20-40 mg) and in an identical or substantially similar form (tablets, capsules) to the inventive drug. In addition, the active substances in the original drug and the generic drug are biologically equivalent - that is, their degree and rate of absorption after the same dose are not significantly different.
Drugs of the same composition may work differently due to auxiliary substances
Therefore, the same therapeutic effects can be expected from both agents. The problem is that original and generic drugs generally differ in the content of excipients (composition of the tablet mass, capsules, coatings), which should not have their own pharmacological effect. It happens, however, that the so-called fillers can cause side effects. There is a risk that in the substitute this "other" component (not the active substance!) May irritate the digestive tract or trigger an allergy. When an inflammation develops in the gastrointestinal tract, e.g. due to lactose intolerance, which is not present in the original drug, but in the generic drug, it is known that absorption will be impaired, so the active substance will also be absorbed differently.
Original and generic statin preparations work differently
Preparations containing a statin are an example of a different effect of original and generic drugs, which is repeatedly described in the medical literature. They are given to people who need to lower their blood cholesterol levels. The use of an innovative drug brings the expected therapeutic effects, while its replacement with a generic preparation does not always satisfactorily reduce the level of total cholesterol and LDL. When the patient returns to the original drug, blood lipids improve.
The effect of the drug may also depend on the multi-layered housing
In turn, with cardiological drugs (for heart rhythm disturbances or hypertension), the half-life of the drug is important, which depends on the structure of the tablet - itsmultilayering causes the drug to be released over time. Are unknown companies able to use such an expensive technology? But as long as generics are manufactured to modern standards and legally approved for pharmaceuticals, they are effective and safe for the most part.
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