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Good or evil: should you be afraid of generics
Many patients, and sometimes doctors, are skeptical about generics - analogues of patented medicines. Nevertheless, Russians increasingly prefer copies of original drugs, which are more affordable.
Many patients, and sometimes doctors, are skeptical about generics - analogues of patented medicines. Nevertheless, Russians increasingly prefer copies of original drugs, which are more affordable. According to the analytical company DSM Group, the share of generics in the Russian pharmaceutical market in the first 11 months of 2018 was 84.6% in volume and 62.8% in value. Rustam Galeev, Medical Director of Teva Russia and Eurasia, is talking to Mednovosti, how fair the claims of consumers to such drugs are.
There is an opinion that generics are of poor quality, slow acting and are less well tolerated
- This is one of the most common misconceptions. The concentration of the active substance of the generic corresponds to the original. The speed and degree of absorption of the active ingredients of the generic is confirmed during the bioequivalence study. The data obtained allow us to conclude that the efficacy and safety indicators of the generic are consistent with the original drug.
Generic production is subject to stringent requirements. In particular, the content of the active substances of the generic must correspond to the original drug, and the requirements for the manufacturing process of the generic must not differ from the original. Drugs that have shown significant differences from the original drug in a bioequivalence study are not allowed on the market.
These rules have been created over the decades and continue to improve. It is their careful observance during the creation, production and circulation of the drug, and not the status of the original or generic, that is the guarantee that the patient will receive a quality drug.
But generics fail clinical trials
- Generic is a copy of the original medicinal product. And for such a drug to appear in pharmacies, the manufacturer must confirm its equivalence to the original. The legislation of different countries, including Russian, provides for different procedures, depending on the type of drug. Most often, a comparative clinical study of bioequivalence is required. We are talking about the rate of absorption and excretion of active substances and the amount of the drug reaching the systemic circulation.
The difference in the testing procedure is determined by the fact that companies must conduct long-term preclinical and clinical studies of a new drug in order to bring an original drug to market. After the expiration of the patent, any pharmaceutical company can produce an analogue of the original drug. That is, generics are carefully monitored to confirm equivalence to the original drug and access to the market, but there is no need for repeated trials on a large group of people due to the identity of the active substance.
The pharmaceutical industry is governed by a set of rules called Good Practices (GxP) to ensure the quality of all drugs without exception. These include:
good laboratory practice (GLP);
- good clinical practice (GCP);
- good manufacturing practice (GMP);
- good distribution practice (GDP);
- good pharmacy practice (GPP);
- good storage practice (GSP);
- good pharmacovigilance practice (GVP).
However, many doctors advise against using generics
- Indeed, some doctors treat generics with prejudice, but not many. Most physicians and pharmacists recognize the value of generics as they make treatment more accessible to patients. At the same time, the lower price of generics is associated not with low quality, but with the absence of the need to recoup the costs of large-scale research, which makes it possible to significantly save on medicines. Thus, according to data posted on the portal of the US Food and Drug Administration (FDA), in the period from 2007 to 2016, the use of generics in the US healthcare led to savings of $ 1.67 trillion.
In addition, the emergence of generics contributes to the development of the market: competition helps to avoid the monopoly of manufacturers of original drugs and, accordingly, to contain the growth of prices.
Why then in developed countries the share of generics is much lower than in Russia
- This is largely due to the fact that these countries are home to many original drugs. However, the situation is changing. And today, in many developed countries, generics are bought more often than original drugs. Let's turn to statistics: if in 2005 the share of generics in the US market was slightly less than 40%, then in 2016 the figures increased to 89.5%. The Japanese government also plans to increase the share of generics: by September 2020, it should reach 80%, whereas now it is 56%.
By the way, the recommendations of the American Association of Physicians prescribe, if possible, prescribing generics, and not more expensive drugs.