What are generics and how do they differ from original drugs?

The COVID-19 pandemic has forced many countriesface a shortage of medicines, including medicines on the list of Vital and Essential Medicines. In 2022, the situation worsened - the rush demand and disruptions in the supply of pharmaceutical raw materials from China and India became a real problem. Most often, pharmacies report shortages of antidepressants, blood pressure drugs, steroids and hormone replacement therapy (HRT). But what to do if the medicine you need is missing from all city pharmacies? A temporary solution to the problem is the so-called generics - medicines based on the same amount (and quality) of the active substance as in the original product, and their effectiveness is a prerequisite. It sounds good, but in practice, many generics are significantly inferior to the original, and buyers are skeptical about them. Moreover, the results of previous studies have shown that the effect of generics on the body can be very different from the effect of original drugs. But why?

Researchers draw attention to the decrease in the effectiveness of generics due to excipients used in their production.

As of 2020, Iceland, Portugal and Canada were the largest users of antidepressants (based on about 153 defined daily doses).

Analogues of original drugs

Generics are a complete copy of the originalmedicinal product, including efficacy and effects on the body. As an example, let's take the popular antidepressant Zoloft from the group of SSRIs (selective serotonin reuptake inhibitors), manufactured by Pfizer. The effectiveness and safety of the drug is confirmed by numerous scientific studies, which is why doctors often prescribe it for the treatment of depression, OCD, anxiety and panic disorder.

Over the past two years, the demand for antidepressantsincreased all over the world, and in Russia consumers of Zoloft increased by as much as 80%. According to RBC, the drug disappears from pharmacies from time to time. So, not a single pack of Zoloft remained in St. Petersburg, and nothing is known about the timing of the resumption of supplies.

Antidepressant "Zoloft" stopped coming to Russian pharmacies due to technical problems in its production

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This state of affairs is a serious problem for people diagnosed with depression. The fact is that treatment for this mental illness rarely lasts less than six months, and the abrupt withdrawal of an antidepressant threatens with many side effects, including withdrawal syndrome. But what to do in this situation?

Most doctors advise patients to switchto analogues of Zoloft, or change the drug. In such circumstances, many choose the first option, switching to generic antidepressant analogues. Generics such as Serlift and Serenata, for example, contain the same amount of active substance, but their effectiveness is hardly comparable to the original - a first synthesized drug that has passed a full cycle of clinical trials.

Analogues of original drugs do not always have the necessary efficiency.

According to the research results,Zoloft's effectiveness is greater than Serlift's - this means that the ability of the drug substance to have the maximum possible effect is different. For example, if the therapeutic effect of Zoloft is more pronounced, then it is impossible to achieve this effect even in high doses with Serlift, says the medsis website.

The situation with the second analogue of Zoloft is approximatelythe same, however, when comparing two analogues, experts advise Serenata because of the greater therapeutic effect. At the same time, the original drug, which disappeared from Russian pharmacies, is the most effective. But how is this possible if the composition of the analogue is completely identical to the original?

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Efficacy and production of generics

Given temporary disruptions in the supply and production of a number of original drugs, millions of people are turning to analogues, also called generic. Recommended by generics and experts from the Worldhealth organizations (WHO) - their dosage form, safety, quality and characteristics are equivalent to the originals (or should be considered as such), and their cost is usually less.

Note that after the invention of the drug,the company receives a patent for the original molecule of the active substance. The exclusive rights to manufacture and sell remain with the company for 20 years, after which other pharmaceutical companies can produce their own generics (the manufacturer of which has the right to change the packaging and assign their own trade name to the drug).

The results of the study in 2017,published in the journal Circulation: Cardiovassal Quality and Outcomes cast doubt on the WHO findings. The authors of the study found that patients taking generic versions of three different blood pressure drugs experienced an increase in the frequency and severity of side effects over several months of use, which means that there is still a difference between the drugs.

Generics are subject to no less stringent quality and efficacy requirements.

Researchers attribute the differences to ancillarysubstances used in preparations - they can be used to give the form of a tablet, capsule or ointment, to ensure rapid solubility or prolonged action; the quality of raw materials matters - in any pharmacological substancethere is a certain proportion of impurities, the amount of which is responsible for the action of the drug. Manufacturers pay great attention to the absorption rate of the substance, its maximum concentration in the blood and the metabolic rate.

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Most often in the production of genericsmagnesium stearate, corn starch, lactose monohydrate, silicon dioxide, aspartame, flavors and colors are used. The low price of the analogue is explained by the fact that the company did not spend money on its invention, safety and efficacy testing (one of the most expensive stages of drug production).

Most generics are manufactured in India andChina, which affects the reduction in the cost of drugs. At the same time, the cost of a generic is not always lower than the original. If the manufacturer initially purchased expensive raw materials and increased production costs, then the final cost may exceed the cost of the original.

A generic drug should have the same effect on the body as the original drug.

At the same time, previous studies have not found much difference between generics and branded drugs, which means that the cause should be sought in other factors. Thus, the permissible difference in the chemical composition of analogues and original drugs should not exceed 20%. The main thing that analogues should cope with isefficiency and safety. Many researchers generally believe that most analogue drugs are just as good at treating diseases as the original drugs.

Read even more interesting articles about the latest discoveries in the field of science and technology on our channel in Yandex.Zen - articles that are not on the site are regularly published there!

Original or analogue - which is better?

So, despite using the sameactive substance, the effect of generics on the body can be very different from the original, as reported by some doctors and their patients. Most often, attention is paid to antibiotics: the original drug Augmentin is sold in pharmacies as Amoxiclav and Femoclav. In this particular case, according to the doctors, the copy is no worse than the original, however, in the case of replacing Zoloft with analogues, the situation is not in favor of the latter.

When testing a generic, auxiliarycomponents may not show a negative effect, retaining all the effects of the drug. However, in practice, side effects and reduced efficacy may occur, which may lead to an increase in the dose of the drug.

Original and reproduced drugs differ in the nuances of production and the composition of auxiliary components

Today generics occupy about 60% of the total drug market, and because of the cost they are purchased better than original medicines.

It should also be noted that the results of previousstudies that have shown that, in most cases, generics work the same way as over-the-counter drugs. Yet in many cases (as with some antidepressants, for example), the copy is less effective, its therapeutic effect is less pronounced, and its side effects are more severe. How do you feel about analogue drugs? The answer, as always, we will wait here and in the comments to this article! Be healthy!