5 Questions About Generic Drugs

On the labeling of generic drugs, you  should put the initials EFG.  It means: Generic Pharmaceutical Equivalent; this allows them to be distinguished.

Despite being prescribed by law instead of brands in Spain since 2011, generic drugs are still surrounded by much controversy and some myths that we will explain later.

Generic drugs were introduced in Spain in 1997. The objective is to save costs while maintaining the efficacy and safety of brand name drugs.

Here are 5 frequently asked questions about generic drugs.

• What is the difference between a generic and a brand name drug?
• Is the quality of generic drugs the same as brand-name drugs?
• Are generic drugs really cheaper?
• What advantages do they have compared to the reference medicines?
• 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 that we can find is the appearance of these drugs with respect to the best-known brands. However, this fact does not imply that the potential of generic drugs varies, as is often believed.

Another difference that we can find is the name of the drug. The generic will be named according to the active ingredient it contains. An example of this is found with paracetamol.

In pharmacies we can find a drug called paracetamol. This corresponds to the generic drug. Or we can find, for example, Gelocatil, which is the brand of a drug that contains paracetamol as an active principle.

However, generics cannot be marketed until the patent on the original drug has expired.

In addition, it must be authorized by the Ministry of Health.

2. Is the quality of generic drugs the same as brand-name drugs?

Yes, the quality is the same. The main differences are the ones we have seen and they have nothing to do with the effectiveness of the drug.

That the quality is the same is guaranteed, since both generic and brand-name drugs are subjected to the same control processes.  In addition, both have to be authorized by the Spanish Agency for Medicines and Health Products (AEMPS). They can also be authorized by the European Medicines Agency (EMA).

3. Are generic drugs really cheaper?

The Ministry of Health is the competent authority when establishing the maximum price of these drugs. It makes sure that the price is considerably lower than that of the reference original.

Therefore, we can safely say that generics are cheaper than brand name ones.  This is because they do not require amortization of research costs. But, as we already know, that they are cheaper does not mean that they have less quality, since this is the same in both.

4. What advantages do they have compared to the reference drugs?

Based on the previous question, we can say that the main advantage of these drugs is the saving of the final retail price. This saving can be up to 60% compared to the price of the original drug.

This price difference is due to the fact that generics do not affect the investments made by each pharmaceutical company to discover a new drug.

5. Is it true that generic drugs contain up to 20% less active ingredient?

No it’s not true. There is no 20% variability in the efficacy of the drug or in the actual content of active ingredient. It is true that there may be a 20% variability in terms of absorption.

However, this variation occurs with any drug, generic or not. This is because when bioavailability studies are done, it is always accepted that it varies by 20%. This corresponds to 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 that is precisely what is taken into account in all studies before the commercialization of generics.