Brands and generics: What's the difference?

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When developing a drug, the pharmaceutical company, and more specifically, its research and development department, finds the right molecule and applies for the use of this molecule. Then, the pharmaceutical company conducts large-scale and expensive trials of a new drug produced by using a molecule found, and, with the successful completion of all required studies, it brings the new drug to the market, acquiring the exclusive right to sell it. The patent protection period of the original drug varies depending on the patent laws in each country. The term of patent protection in most world‘s countries will expire in 20-25 years, and taking into account that the release of the drug in the market takes about 13-15 years, we may say that the company has a total of 8-12 years to return the funds invested in the drug development.

After the expiration of the new drug patent protection period, generics appear in the pharmaceutical market.

Generic is a drug, therapeutically, pharmacologically and biologically equivalent to the original. Generics have the same active ingredient as the original drug, and usually generic drugs are equally effective, but cost significantly less, which ensures increasing popularity of the generics. Generics are sold either under the international non-proprietary name, or under a proprietary name that is different from the name of the original drug.

Why then are the generics cheaper than the original drugs? Many buyers associate a lower price with lower quality. Is it true?

Generic manufacturers do not have to bear the huge costs: the company-developer of the original drug has already spent a fortune on testing of the active ingredient. Generic manufacturer has only to prove the equivalence of the generic to the original. This allows them to offer the buyer a lower price. On the other hand, since they do not invest enough money into clinical trials doubts in their lower quality are somewhat justified.

To answer the question of whether the generic drug has the same safety profile as the original drug it is necessary to prove its therapeutic equivalence of the original drug: to carry out the required clinical trials of the generic drug on patients, conduct comparative clinical trials of the original drug and the generic drug, thoroughly investigate the safety profile of the generic drug. These studies are particularly important in the case of preparations for the treatment of chronic diseases: patients are taking many of them during a significant period of their life. Unfortunately, these trials are not mandatory and often are not carried out.

The poor quality of generic drugs is often due to the fact that in order to save (active substance is about half the cost of generic) the cheapest active substance is purchased, respectively, it is of lower quality. Frequently substances for generic drugs (generics), also in order to save, are produced in the countries with weak control over the production of drugs, where the active substance manufacturing process is often simply not controlled. Methods of synthesis may also be changed.

In addition to the active substances, the drugs also include excipients. Any change in their composition may lead to changes in the drug quality, as well as cause allergic or toxic manifestations with the patient.

The side effects should not be remembered as well. Generic can reach 70-100% efficiency in relation to the original drug. But this figure also concerns the side effects. For example, a patient who took the original Pfizer Viagra and did not experience any side effects may experience them in full after taking Generic Viagra. When it comes to elderly patients or patients with serious health problems, it is necessary to be extremely careful when changing the original drug to generic.

Therefore the patient before going to the pharmacy for the drug should be very clear about the drug of which manufacturer he is going to buy.

That is, on the one hand, a possibility to buy drugs at a more affordable price is very important, especially given the population aging. But on the other hand, the lack of necessary research casts doubt the quality of many generics.