What Is a Generic Drug?

These days. there are two large groups of drugs, brand name and generic. This last group has a lower price, but people don't trust them as much.
What Is a Generic Drug?

Written by Luis Rodolfo Rojas Gonzalez, 25 April, 2021

Last update: 25 April, 2021

People have long relied on brand names when it comes to drugs, because of their effectiveness. However, in recent years, there has been an increase in the production of generic drugs, which provides the same effects for a lower price.

The treatment of diseases that affect humans evolved over the years. Society went from applying natural substances without any dosage to the use of specific drugs. The first laboratories to synthesize drugs quickly became popular and trusted by the population.

It’s important to bear in mind that drugs are made up of an active substance and excipients on a large scale. The active principle will be responsible for generating the pharmacological effect, an example of this is paracetamol. For their part, excipients give drugs qualities to facilitate their use.

What is a generic drug?

A generic drug is similar to the original.
Today these drugs represent a good part of those prescribed in public health.

A generic medicine is defined by the Law of Guarantees and Rational Use of Medicines and Health Products as “any medicine that has the same qualitative and quantitative composition in active principles and the same pharmaceutical form”.

In short, these are compounds that have the same pharmacokinetic and pharmacodynamic properties as a reference drug. This type of drug must pass a large number of studies and tests that show that they have the same bioavailability and effects in the body.

All these compounds must have a different appearance to the drug that gave rise to them. In addition, it’s important for them to be named based on the active ingredient used and not the laboratory. The label of these drugs must have the acronym EFG, which stands for Generic Pharmaceutical Equivalent.

The drugs currently on the market have a patent, and so a generic drug can’t be marketed until this patent has expired.

The differences between a generic and a brand-name drug

At present, there are no major differences in the composition of the drugs. By law, generic and brand-name drugs must use the same active ingredient. This means that they must be the same in their chemical structure, have the same dosage, and produce the same effect.

These compounds must also have the same format(s), in order to make them very similar in their administration. The main difference between both types of drugs lies in their appearance, which must be very different in order to avoid legal problems.

In this sense, generics must use different colors from those used by the brand-name drug, and they must also incorporate the acronyms mentioned above on their label. Experts say that the manufacturing and marketing process for brand-name drugs takes longer.

The above statement is due to the fact that brand-name drugs need to carry out research, development, and clinical studies. On the other hand, a generic drug follows the same manufacturing process established by the industrial brand, although they can add extra excipients or incorporate some form of innovation.

Advantage

The main advantage of generics lies in their sale price. According to the data offered by the Spanish Association of Generic Medicines (AESEG), they’re between 40% and 60% cheaper than brand-name drugs.

The decrease in the price is due to the fact that they haven’t had to cover all the expenses incurred in the research and study phases. This means savings for the common citizen, who will have to pay less for a generic drug, but will obtain the same benefits and even the same benefits.

This type of medicine also contributes to the rationalization of public spending as it reduces pharmaceutical bills. By reducing the cost of these bills, local authorities can invest money in other health areas of greater need.

Trademarks aren’t harmed by generic drugs, as they can only circulate when the patent expires. This legal document can be valid for a period that can vary between 10 and 20 years, which is usually enough to recover the money invested.

Most frequent myths about generic drugs

A generic drug goes through research phases.
Governments rigorously ensure that generic drugs are similar to the originals.

Although the use of generic drugs is increasing around the world, there are still many myths and questions about them. One of the statements that we hear most frequently is that they have 20% less of the active ingredient, however nothing could be further from the truth.

Multiple studies ensure that a generic drug has the same bioequivalence as its brand-name counterpart. This means that both compounds have the same dose of the active ingredient and are capable of producing the same reactions in the body.

What is true is that its absorption can vary by 20% depending on individual variables present in each person. However, this isn’t a phenomenon that’s unique to generic drugs, as it can be observed even between 2 different batches of a brand-name drug.

It’s also possible to hear people say that a generic drug doesn’t have the same legality as a brand name. However, these must pass multiple tests to demonstrate their effectiveness and, thus, be able to receive approval from the authorities.

Among the entities in charge of authorizing the commercialization of generics are the individual agencies of each country, as well as the European Medicine Agency (EMA). In the United States, the authority in charge of verification is the US Food and Drug Administration (FDA).

Safe compounds with effective results

A generic drug uses the same active ingredient and even the same excipients as its brand-name counterpart in most cases, thus generating the same pharmacological effect. The only appreciable differences are in their appearance and price, as generic drugs are cheaper.

All available drugs, including generics, can trigger unwanted side effects, and so their use must be in accordance with prior medical authorization.

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