While we answer several questions regarding generic drugs throughout this article, we need to know what exactly they are first.
The definition of generic drug is as follows: “any medicine that has the same composition in active ingredients, both in qualitative and quantitative terms, and the same pharmaceutical form with respect to an original or reference drug”.
What are generic drugs?
The wording “Medicinal Equivalent” must always be present on the label of generic drugs. This wording allows you to distinguish them, along with other details such as the name and packaging.
Despite having been required by law in Italy since 1996, generic drugs are still shrouded in controversy and some myths that we will explain in this article. In 2006 they went from “generic” to being indicated as “equivalent”, to assure consumers that these medicines had a clear specificity.
They represent an undisputed advantage in terms of prices, as they do not include research, marketing or advertising costs; they can therefore apply lower rates, while maintaining the efficacy and safety of branded drugs.
In the following lines we answer 5 frequently asked questions regarding generic drugs.
- What is the difference between a generic and a brand name drug?
- Is the quality of generic drugs the same as that of brand name drugs?
- Are generic drugs really cheaper?
- What advantages do they have over reference drugs?
- Is it true that generic drugs contain up to 20% less active ingredient?
1. What is the difference between a generic and a brand name drug?
The main difference between these drugs compared to the more well-known brands concerns first of all the appearance. However, this does not imply that the effectiveness of generic drugs is inferior, as is often believed.
Another difference you can easily notice is the name of the medicine. The generic drug will be named after the active ingredient it contains. An example of this is the popular acetaminophen.
In fact, in Italian pharmacies, the most commonly sold product has the name of Tachipirina. But, as just explained, the generic versions will use just the same name as the main formula. And this applies to any medicine.
Generic drugs can be marketed only after the patent of the original drug has expired, with the authorization of the Ministry of Health.
2. Is the quality of generic drugs the same as that of brand name drugs?
Yes, the quality is the same. The main differences are the ones we saw in the previous paragraph and have nothing to do with the effectiveness of the drug.
There is a guarantee of drug quality, since generic and branded drugs are subject to the same control procedures. In addition, both must be authorized by the Italian Medicines Agency (AIFA) or the European Medicines Agency (EMA).
3. Are generic drugs really cheaper?
The Ministry of Health is the competent authority that sets the maximum price for these medicines. It ensures that the price is significantly lower than that of the original patent.
We can safely say, therefore, that generic drugs are less expensive than branded ones. This is because they do not need to amortize their research costs. But, we reiterate, the fact that they are cheaper does not mean that they are of worse quality, which is the same in both.
4. What advantages do they have over the reference drugs?
Based on the previous question, we can say that the main advantage of these drugs is the savings in the final retail price. Keep in mind that they can be priced up to 60% lower than the original drugs.
This price difference is due to the fact that generic drugs do not have an impact on the investments made by the pharmaceutical company to research and test the drug.
5. Is it true that generic drugs contain up to 20% less active ingredient?
No, that’s not true at all. There is no 20% variability in the efficacy of the drug or in the actual active ingredient content. What can be highlighted, in some cases, is a variability of 20% in the level of absorption of the drug.
However, this variation occurs with any drug, generic or otherwise. The reason is due to the fact that when bioavailability tests are performed, a variation within 20% is always tolerated. This is the individual pharmacokinetic variability of any drug.
This means that although the total amount of active ingredient is exactly the same, the absorption can vary. And this is precisely what is taken into account in all studies prior to the commercialization of generic drugs.