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Medicinal generics: when “cheaper” does not mean “worse”

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Meddirekt 24
Medicinal generics: when “cheaper” does not mean “worse”

You probably noticed that in the prescription, doctors indicate the active substance that has the main therapeutic effect, and not the name of a particular drug. And when you come to the pharmacy, you often have the opportunity to choose what to buy according to this prescription - the drug is more expensive or cheaper. The same is true for over-the-counter drugs. Why? Because the “more expensive drug” is usually the original produced by the pharmaceutical company that developed it, and the “cheaper” one is the so-called generic, a drug reproduced by another company with the same active ingredient, a non-proprietary version. Don't be put off by this add-on or their lower price - the explanation goes on.


Only statistics


In most European countries, generics have a market share of over 40% by volume. Germany, which is the largest pharmaceutical market in Europe, had the highest share of generics by market size in 2014 at 73%. In the UK, which ranks fourth in Europe, the volume share of generics in the same year was 66%. With the market share in money, the situation is similar to the Russian market - 40% on average in the EU. If we continue to consider the structure of the market, it turns out that the production of generics is carried out by reputable companies with a worldwide reputation, which are usually associated with innovative medicines. According to data for 2020, Mylan Pharmaceutical Company, which is 57% owned by the American Pfizer, earned the most on the sale of generics - only $ 10.8 billion. The second place was taken by the Israeli Teva Pharmaceuticals with a result of $ 9 billion. In third place is the Swiss Novartis - it generics brought in $8.6 billion. In fourth place was Indian Sun Pharma, which is somewhat more associated with generics, which earned $4 billion. Pfizer itself was in fifth place with a “modest” result of $3.5 billion. So almost all companies are engaged in the release of generics in the market, except for those that, due to their business model, focus only on cutting-edge developments.


Generic ≠ analogue


Although both concepts sound very similar to the average buyer, and they are often confused in the media, there is a significant difference. A generic is a drug that is identical to the original in composition and therapeutic effect, but is produced by a different manufacturer. The original drug and the generic contain the same substance, so the therapeutic effect should be the same. Analogues are a completely different group of drugs that is aimed at treating one disease or symptom, but they differ from the original in composition, dosages, side effects and contraindications. For example, Viagra has a huge number of generics on the market, the most famous of which is Kamagra. But there are even more analogues - these are all preparations based on sildenafil, which have a positive effect on male power. The most prominent example in this category is Cobra 120mg.


Almost free


In fact, generics are cheaper only because manufacturers have significantly lower costs compared to the original drug developer. A patent on a drug or its use for a specific disease provides time-limited drug exclusivity. As a rule, this is 20-25 years from the date of filing of the application or 10-15 years from the date of the launch of the drug on the market. During this period, other companies that did not participate in development and research cannot copy the created medicine and bring it to the market. When a company introduces a new drug to the market, significant funds have already been spent before the sale: on research, development, marketing and promotion of the drug. It is somewhat easier for generic manufacturers in this regard. There is already a demand for the drug, except for the opening of production, only minimal investment in marketing is needed to introduce the new product to buyers. In addition, if several companies are interested in production at once, competition between them will further reduce the price. As a result, everyone wins: manufacturers can compete for a new niche if technological capabilities allow, and buyers receive identical drugs at a lower cost.


Under tight control


In some cases, the scheme works differently - the company that develops the original drug itself is looking for manufacturers to produce a generic, especially if patent protection (gives the creators of a new drug the exclusive right to produce and sell it - ed.) ends soon. Due to this maneuver, the company itself can choose a suitable manufacturer and agree with him on pricing policy, market share and quality issues.


What does science say?


A Canadian study published in the October 2017 issue of the journal Circulation: Cardiovassal Quality and Outcomes analyzed the difference in efficacy between brand-name and generic high blood pressure drugs. The researchers studied the number of emergency room visits and hospitalizations among 136,000 people over 66 who were taking any of three blood pressure medications: Losartan, Valsartan, and Candesartan. They looked at data from 24 months before and 12 months after generics of these drugs hit the market. As a result, it turned out that before generic versions became available, about one in ten people taking medication for high blood pressure had to go to the emergency room or be hospitalized every month. Within a month after the start of the use of each of the generics, the frequency of these adverse events increased: by 8% for Losartan, by almost 12% for Valsartan and by 14% for Candesartan. Formally, the numbers indicate that the number of side effects has increased, but the essence lies in the details. The study did not track one group, namely people who took the branded version of the drug and then switched to the generic version. Instead, the researchers looked at all people who had problems after taking the generic drug, whether they had previously taken the original drug or not. This means that some people who have never taken brand name medications have had problems after they started taking generic blood pressure medications. They might have had the same problem if they were taking a branded drug. In addition, because patent medicines were more expensive, it is also possible that a disproportionate number of elderly and sick people who could not afford patent medicines could now take generic forms. This group of new users may have been more prone to side effects due to the nature of their health rather than the quality of the generic drug.


For all


In general, the use of generics benefits everyone: both the pharmaceutical industry and patients. Generic drugs cost many times less than the original drugs, and the therapeutic effect is usually completely identical. As a result, medicines become more affordable for a larger number of buyers, due to the low price, the healthcare budget is also optimized, which makes it possible to allocate funds for the treatment of rarer diseases. With all this, it is important to remember that it is not worth changing the drug prescribed by the doctor for a generic drug on your own. Manufacturers usually limit themselves to conducting bioequivalence studies, which is consistent with the legal requirement. The therapeutic effect usually coincides, but in some cases, the individual characteristics of each person may come into play, for example, the reaction to an excipient (an inactive ingredient that is added to a pharmaceutical compound - ed.), which was not in the original drug. Therefore, all changes in prescribed drugs should be carried out only after consulting a doctor, even if the active substance in the drugs is the same, and the new generic is significantly cheaper than the original.

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Meddirekt 24
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