It is worth taking a closer look at the specifics of generic drugs, as the differences between generic drugs and the original drugs may go beyond the price difference.
What are generic drugs?
The term generic drug defines a preparation that is a replacement (reconstruction) of the original drug, which in practice means that it has a core identical to the original - a drug (active) substance. It is introduced to the market after the expiry of a patent that protects the original drug for a period of up to 20 years from its market launch.
Generic drugs do not have to undergo the obligatory clinical trials for innovative drugs, which allows for a significant reduction in their price - thanks to this they have gained favor governments and the patients who benefit from them. However, treating generics as an ideal prescription - a cheap and effective replacement for the original drug, is not always possible.
Similarities and differences
The common denominator of original and generic drugs is the active substance responsible for the key therapeutic effect of the preparation. However, the presence of the same active substance does not mean that the originator and the generic drug are identical. The difference between an innovative drug and a generic is related to auxiliary and stabilizing compounds. In a generic drug, they have a different method of purification and synthesis, which may affect the effectiveness of the drug or the occurrence of differences in its safety profile. Usually, generic preparations do not pass full laboratory tests, the costs of which constitute up to 70% of the costs related to introducing a drug to the market. This is why their price may be lower than that of innovative drugs.
Conditions for admission to the market
The formal condition for admitting generic drugs to marketing is meeting the bioequivalence criteria, i.e. proving that the replacement drug works in the same way as the original drug. This procedure takes an average of one to two years. However, the generic preparation tested in bioequivalence studies is administered only to he althy volunteers, and not to sick people, as in the case of research on innovative drugs. Re-testing of clinical and preclinical tests is also omitted, which is what companies producing original drugs are required to do. Moreover, the above procedure does not applyfor all generic preparations - e.g. topical drugs are exempt from the bioequivalence test.
Different faces of generics
Theoretically, all generic preparations must meet certain quality conditions, resulting from production conditions. The assumption of an appropriate efficacy and safety profile is to result from the bioequivalence study. As Dr. Sławomir Badurek, vice-president of the Kujawsko-Pomorska Izba Lekarska (Kujawsko-Pomorska Izba Lekarska), a specialist in diabetes and internal medicine, points out, the fact that generics meet the requirements cannot always be treated as a quality certificate.
- The US Food and Drug Administration (FDA) has been examining all generic drugs entering the market since 1938. Each person is assigned a two-letter code, which determines their therapeutic equivalence with the original. If the first letter of the code is A, the FDA has recognized the product as being therapeutically equivalent to the originator drug. The letter B informs about differences in therapeutic equivalence that do not allow the drug to be considered a substitute. For therapeutically equivalent drugs (labeled A), the second letter of the code contains information about FDA bioequivalence testing. If the medicinal products are completely (therapeutically and biologically) equivalent, the generic is denoted by the symbol AA. Otherwise, their bioavailability after administration in the same dose is "substantially similar" in terms of efficacy and safety (the replacement is marketed with the AB mark). This definition is vague and allows for deviations, the doctor explains.
Generic: identical or similar?
The therapeutic equivalence of a generic may be disturbed by several factors. One is a different form of generic drug. It can be in the form of tablets, dragees, capsules, as well as with the use of various systems to prolong the action of the drug. These factors affect the speed of activation of the drug substance, which in turn translates into drug efficacy and the frequency of side effects. The presence of different substances in the core or filling of the preparation is associated with the risk of the so-called decomposition of a generic drug, as active substances may react with the tablet coating. The lower stability of the preparation may also determine its resistance to storage conditions (temperature, humidity) and the speed of aging of the drug.
- It may happen that the differences between two geneticists will be greater than the differences between each of them separately and the original. In addition, internal control standards vary from manufacturer to manufacturer. There are better and worse generics, so they always should belisten carefully to what the patient says, who has stopped using the original drug in favor of generic - says Dr. Sławomir Badurek
Development versus costs
Supporters of the wide use of generic preparations point to the benefits of popularizing cheap drugs and the possibility of choosing a therapeutic product. However, many experts point to the danger of being flooded with cheap drugs of dubious quality from India, China and Brazil.
- Without adequate patent protection, it would be unprofitable to bring new molecules to market. It should be considered whether the level of protection is sufficient in a situation where the number of innovative drugs decreases - comments Dr. Badurek. - I understand that the patient expects access to modern, effective and at the same time cheap drugs. However, the combination of these three features is not always possible. It should also be noted that innovation in the pharmaceutical industry is of particular importance. We must remember that, according to WHO data, we do not know the effective treatment of 75% of 30,000 diseases occurring in the world - concludes the doctor.
Patient choice
Thanks to innovative products, the development of pharmacy allows for more effective treatment. Generics, in turn, allow for savings: both in family budgets and in he althcare systems.
- The presence of generics positively stimulates the market, so I am definitely in favor of their wide availability - comments Dr. Badurek. - However, I believe that the patient should know that a generic is not the same as the original and that a generic is not equal to a generic. Unfortunately, sometimes even doctors lack this knowledge.