What is a generic?
After the expiration of the patent on the original drug, generic drugs appear on the pharmaceutical market, which, by law, must be copies of the original pill. And they should be cheaper because manufacturers do not need to spend money on their development, they work with a ready-made dosage form, there is no need to conduct research, to prove the safety and efficacy of the drug – this was done by the developer company. That is why the price of a generic is significantly lower. Although the requirements for the production part and the original and the generic should be absolutely the same, but in practice this is not always the case. In the modern world, the cost of generics varies significantly – from expensive to extremely cheap. This is also an explanation. The fact is that the preparations must be made in accordance with the requirements of the GMP standard (high-quality manufacturing practice). In addition, the World Health Organization (WHO) has special requirements for bioequivalence (similarity) of generics to the original drug, namely, it is required to determine the full match of all fillers and dyes in the original and generic drugs and proof of exactly the same effect as the original and generic drugs. Those generics who have gone through all these stages of research are expensive because really made from the proper raw materials and are similar to the original drug. In turn, those generics that have undergone only laboratory-defined bioequivalence are very cheap, and in addition to the reduced therapeutic effect, they often have unpredictable side effects uncharacteristic for one or another type of drugs.
The danger here is as follows. Although it is said that a generic drug is identical to the original, but this is not a complete copy of it and cannot be it, because the manufacturer relies only on a patent, that is, only on a chemical formula that can be viewed on the Internet, textbooks and other benefits. At the same time, the process of synthesis, that is, how to get certain substances for tablets, is protected by a licensing agreement, because the manufacturer of the original drug must make the public only its formula, and its obligations to the medical community end there. No one is authorized to force her to disclose all the secrets of production.
Therefore, a generic is always synthesized and produced in other ways. In America, generics make up 1⁄4 of the pharmaceutical market, in Germany –1/3, in the UK –1/2, of all drugs.
Why are original drugs expensive?
This is because newly synthesized drugs from the very beginning of their journey are checked for safety and efficacy in all possible and impossible ways, for which a lot of clinical trials and research involving a huge number of people and technical resources are carried out, and research takes about 10-15 years. During the research, out of 10,000 thousand drugs reach the drug stage no more than 5. The pharmaceutical company bears all the costs of creating the drug, including for those who have not gone through the research, on their own, so they are included in the price of the new drug. It also includes marketing expenses, training of doctors and pharmacists, spending on post-marketing research for several years after the drug was launched to the market in order to obtain broader data on its safety. On average, the withdrawal of one drug requires about two billion dollars, and during the patent protection period, the pharmaceutical company tries to recoup its costs as soon as possible, make a profit, and also invest the earned money for the subsequent development of new drugs, otherwise it will not be all right no point. That’s all the reasons for the high cost of the original drug.