A generic drug is the therapeutic equivalent of an original pharmaceutical product, the patent of which has expired. It contains the same active ingredients as the original and is essentially equivalent and therefore interchangeable with the brand.
A generic medicine is placed on the market in accordance with international patent laws. More and more doctors prescribe these effective alternatives instead of the higher-priced branded medicines.
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Is there a difference between brand and generic?
Whether a brand-made medication made by a large pharmaceutical company works better than a generic drug is a question that researchers, doctors and patients have been working on for a long time.
GPs will often prescribe generic versions, since these drugs should work the same as the branded medicines and are a lot cheaper.
Patients are often skeptical when they switch from a branded medicine to a generic medicine. It may be that one is more likely to suffer from side effects, or even that the other version of the same drug is less effective. Even when people buy freely available medicines, such as a cream for cold sore or painkillers for headaches, many choose to pay more for a brand than to just trust a brand.
Difference between branded and generic medicines
When a pharmaceutical company develops a medicine, this company has the sole right to produce this medicine for a certain period of time. When this period has expired, other companies can also make and sell the medicine, but always only under a different name than the original product.
This medicine was put on the market in 1998 by Pfizer. The patent was valid for 15 years. In 2013, other pharmaceutical companies were allowed to make their own versions of this drug.
Because Pfizer has a patent for the indefinite term Viagra, other companies have to sell their versions under a different name (in this case under the name Sildenafil, which is the name of the active ingredient).
These generic pills usually contain the same doses as the marker and thus contain the same amount of the active ingredient. However, the pills can have a different composition because they contain other auxiliary substances, such as the substance that serves as a coating.
There should therefore, theoretically, be no (or only very little) difference in the functioning of the two versions of the same drug.
Can these small differences have an effect ?
Generic drugs are always tested before they are released to check that they have a similar effect to the original medicine. The term “similar”, however, is open to interpretation, which may lead to possible differences in effect.
“The companies get a lot of freedom in the production process of the medication. As long as the bioequivalence is within a certain value, the medicine is considered the same, but the outer values can already make a big difference in the user experience.”
Brand medicines are often further developed, simply because they have been available for some time. Another factor that can have a big impact is that the brand versions have been available for a longer period of time, which is why scientists have had a longer time to make the composition of the drug as beneficial as possible, for example by adding other excipients, making the drug more effective. may be more effective or cause fewer side effects. ”
However, pharmacists think that the patient’s perception also plays an enormous role. Many of the differences between the brand and generic drugs that patients experience can be attributed to patient perception, patients’ beliefs and what other health-care experiences they have.
How the patient experiences the consultation in which the medicine is prescribed can play a role in the expectation of how effective the medicine will be – a medicine that is prescribed during a consultation that the patient experiences as positive, for example because feeling that the doctor has listened to their problem or because the patient has been able to decide himself or herself, will usually be better received If the doctor does not consult the patient when making their decision, for example to prescribe another version of the same drug , this may result in the patient becoming uncertain about the effect of the medicine.
Are generics as good as branded medicines?
Yes. Generic medicines must meet exactly the same requirements that are imposed on all other medical products when it comes to quality, safety and effectiveness. Manufacturing takes place in controlled production locations according to the Good Manufacturing Practice guidelines.
Moreover, the same applies for generic medicines as for branded medicines; Once medicines are on the market, they are constantly monitored by the manufacturer, just like branded medicines. Every report of an update is then reported and fed back.
Are generic medicines actually cheaper?
Yes and the savings are significant. Generic drugs are on average 20 to 80% cheaper than branded medicines. In addition, manufacturers of branded drugs are forced to lower their prices after – sometimes even before – expiry of the patent, due to competition with generic medicines.
Do generics use data from brands ?
The same EU directives apply to generic medicines as to branded medicines. Applicants for an approval for generic medicines do not use data used for registration of the branded medicine. Because generic products contain the same known, safe and effective ingredients, the pre-clinical tests and clinical trials carried out for the specialty are not repeated.
The safety and effectiveness of a generic medicine is investigated by comparing the generic medicine with the information from the brand medicine file. Health authorities have sole access to this information from the files of branded drug manufacturers. This information is never made public to third parties and therefore can not be used by the producers of generic medicines. It would go unethical and against international agreements to do this.