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Generics are cheap analogues. Key differences from the originals.
The article talks about how generics differ from original drugs. their legal status. How not to make a mistake when choosing a particular product
2023-03-29 Author: DarkSideLaboratories Reading time: 2 min
The idea of generics
Generics are drugs that contain the same active chemical substance, identical form of release, efficacy, medical prescriptions and safety as original medicines, but do not have patent protection.
In other words, generics are therapeutically, pharmaceutically and biologically equivalent to original products, but, as a rule, have a lower price. From the definition of "generics" it is clear that "patent protection" is their key difference from the originals. Let's take a closer look at the concept of "patent protection".
A patent is a legalized monopoly.
A pharmaceutical company, releasing a new product or starting its import into a new country, seeks to obtain a patent. The patent gives the right to the sole company-the patent holder to produce and distribute the drug on the territory of this country. By obtaining a patent, the company acquires a legalized monopoly protected by the state, which allows you to set any prices, with an artificially created, complete lack of competition. Pharmaceutical companies, chasing profits, use this opportunity by assigning the highest possible prices at which, according to preliminary calculations, the drug will be in demand by the market of this particular country. This is called a "wholesale surcharge". A number of countries exercise state control over the "wholesale surcharge" (Israel, Canada). The USA and Russia do not regulate this pricing factor.
The patent is valid for 20 years. (In the USA -17 years). The patent may be extended. (in Russia – for 5 years). A number of countries exclude such a possibility. After the expiration of the patent, any pharmaceutical company has the right to start producing generics. After the release of the first generic version of the drug (generic), the price of the original drops sharply, an even more noticeable drop in price occurs after the release of the second version of the generic.
In fairness, it should be noted that the creation and launch of new medicines on the market is a long and expensive process that takes 6-10 years. The cost of the project varies from $ 1 billion and above. By the time a new drug appears on pharmacy shelves, the developer company will spend a lot of money on research and clinical trials. There is a strictly limited period of time (20 years) from the date of receipt of the patent protecting the developer company until the appearance of the first competitors that negatively affect profits and sales volumes. In an effort to recoup investments as soon as possible and get the maximum profit, pharmaceutical companies set the maximum possible "wholesale premium", using the temporary position of the monopolist to the maximum.
Production of generics
Generic manufacturers do not spend money on the development of medicines. Resources are spent only on production. Bioequivalence and compliance with the standards of the original drug is the basis for the approval of generic drugs (generics). This is what all the efforts of the manufacturer are focused on.
Generic manufacturers are deprived of the privileges of a monopolist. When pricing, it is necessary to take into account the prices of competitors, the needs of the market, as a result, to assign competitive market prices. The combination of the above factors leads to a significant reduction in price compared to the original. In the case of generics, the market, not the monopoly, determines the price.
Registration of generics
Let's take the example of the USA. Upon expiration of the patent, any pharmaceutical company that has decided to produce jenirik submits an application (ANDA) to the FDA. (ANDA is a simplified application for new medicines). The FDA (Food and Drug Administration), having made sure that the generic is bioequivalent to the original, is safely produced, has the necessary labels, approves the application and adds it to the list of approved medicines (FDA Orange Book). After that, the generic enters the market.
Generics or originals
This is a matter of marketing and advertising. Pharmaceutical companies spend huge amounts of money on advertising. Viagra's advertising budget for 2011 is $400 million. It is not surprising that after hearing the phrase "erectile dysfunction", 95% of people have a firmly established association – Viagra. People tend to believe advertising and pharmacists. It is beneficial for the latter to convince patients of the superiority of originals over generics for one simple reason, by selling originals you can earn more. Agree, it's better to get 30% profit from $ 500 than 30% from $200 by selling generics. Often, it is more profitable for doctors to prescribe originals, because receiving "bonuses" from distributors serves as a good motivator, while at the same time being a pleasant salary increase.
In addition, if a certain drug helps the patient, it is unlikely that he will want to change it. Generics may contain excipients (inactive components) that do not affect the effect of the drug, but change the color and / or taste. The form of generic pills may vary. For these reasons, the average person will decide that this is a completely different drug. Subjective feelings can play a role in the choice.
Recommendations for choosing generics
- to search for the drug by the active chemical.
- compare the prices of found medicines from different manufacturers, taking into account the dosages contained
- do not be afraid to order medicines abroad, having previously studied the legislation of the importing country. The price of the same product from the same manufacturer in different countries may differ significantly.
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