Generics (generics, generics, generic drugs, generic drugs) (English Generic) are medicines with proven pharmaceutical, biological and therapeutic equivalence with the original. That is, medicines having the same composition of active substances, dosage form and effectiveness, as well as original preparations, but not having patent protection. They may differ from the original preparation in the composition of the auxiliary substances. Are placed on the market after the expiration of the patent protection of the original products.
The necessary requirement for the sale of generics is the proven pharmaceutical, biological and therapeutic equivalence with the original.
The price for generics is much lower than for original drugs, while generics do not differ from the original tools for efficiency and safety, and are manufactured in strict accordance with established regulations and quality standards.
The use of generics is of great medical and social importance, since it makes quality treatment affordable for the general population. For example, in the United States today, more than 60% of all prescription drugs are generics. Similar statistics are also observed in Western Europe: Germany, Austria, Switzerland, etc.
The widespread use of generics makes it possible to spend more rationally the national budget allocated to health care, and, thus, to create a financial reserve for the payment of expensive medical products, procedures and services. In turn, price competition from generic manufacturers pushes innovative companies to create fundamentally new, more modern drugs and methods of treatment.
The emergence of generic drugs is associated with the features of patent protection of medicines. The developers of the original active substances spend a lot of time and resources on their production and, of course, want to get dividends from this. Since the discovery of the drug before it reaches the final consumer, it takes 10 to 15 years, while patent protection is legally possible only for 20 years. At the end of the patent, the drug formula can be reproduced not only by its developer, but also by any other pharmaceutical production. The changes do not concern the active substance, but auxiliary, as well as production technologies, can be changed. The effectiveness of generic drugs should be proved by tests for bio- and therapeutic effectiveness in comparison with the original drug. Tests are mandatory, and without carrying out the necessary studies, generic drugs will not be released to the market.