Generic drugs are used by thousands of people daily. However, many people do not know exactly how they differ from reference drugs.
They are often chosen for pharmaceutical recommendation or for financial reasons.
In this text we will explain to you exactly what generics are. You will also understand how they differ from so-called reference drugs and similar drugs. In addition, we will see factors such as its security, price and advantages.
What are generic drugs?
Generic medication is one that does not have a commercial name, but that is sold based on its active ingredient (drug). This must present the same dosage, pharmaceutical form and must be administered by the same route as the reference drug in the country.
That is, it has the same characteristics and must produce the same effect as branded drugs (reference). In addition, it undergoes strict tests to ensure its quality and effectiveness.
For the drug to be considered interchangeable (equivalent or safe to exchange) with the reference drug, it must pass bioequivalence and bioavailability tests submitted to the National Health Surveillance Agency (ANVISA).
Francielle Mathias, a pharmacist, explains that the tests serve to “compare generic and similar drugs to the reference drugs” and that “they are used to prove the quality, efficacy and safety of these products”.
Only after being considered fit by the tests, does the medication become authorized for its registration and commercialization.
What is the difference between generic, reference and similar?
We have seen that the generic acts as an alternative to the reference drug. But what characterizes a drug as such?
In addition, there is also the similar drug. What is its difference and characteristic?
Let’s see to follow:
A medicine is called a reference when it comes to an innovative formula. That is, a new medicine registered in the country.
It is also common to call it a “branded medicine”, considering that it needs to have a trade name (brand) on its packaging in order to be made available for sale.
Like generics, before obtaining authorization for registration and commercialization, reference drugs undergo a series of rigorous tests. In this way, it is possible to prove its effectiveness, safety and quality.
Due to the research time and the money invested, the formula developer laboratory gains the exclusive marketing right during the patent period. This period can last from 10 to 20 years.
The development of a new drug can cost around 2.6 billion dollars. This is the main reason for the patent to expire only after a long period of time, since the expectation is that part of the money invested will have a return from the exclusive sale of the formula.
After expiration, the formula can be used by other laboratories, giving rise to new options (generic and / or similar).
In addition to reference drugs and generics, we have similar ones.
According to Law No. 13,235 of 2015, the similar drug can be characterized as one that has the same active ingredients (drugs), pharmaceutical form, route of administration, dosage, pharmaceutical indication and concentration as the reference drug.
However, the same Law explains that it may differ as to “the size and shape of the product, expiration date, packaging, labeling, excipients and vehicles”.
Pharmaceutical Francielle Mathias explains that the vehicles are therapeutically inactive ingredients and that they transport the active substance. They are usually present in the formulation of liquid remedies (for example, syrup).
Like the reference product, the similar product must always have an identification by trade name or brand.
It is worth mentioning that the similar also needs to prove its effectiveness, safety and quality to ANVISA, undergoing bioavailability and pharmaceutical equivalence tests.
Are generic drugs safe?
Yes. Generic drugs are safe due to the rigorous tests that are submitted before their registration and commercialization. Thus, once the authorization was issued by the National Health Surveillance Agency (ANVISA), the generic can be considered interchangeable with the reference drug, that is, it can replace it according to medical advice.
Why is the generic medicine cheaper than the reference medicine?
In general, generic drugs are cheaper because they do not include costs related to research for the development of its active ingredient (drug). In addition, as they do not have a brand, there is no expense on advertising, resulting in cheaper products.
What are the advantages of generic drugs?
The National Health Surveillance Agency (ANVISA) points out the advantages of generics:
- The availability of lower priced drugs to consumers. This is because the generic must be at least 35% cheaper than the branded drug;
- Reduction in the price of the reference drug, considering the possibility of competition (generic and similar drugs);
- Contribution to ease and increased access to medicines with certified quality, safety and efficacy.
Is it possible to exchange a reference drug for a generic one?
Yes. For a generic drug to obtain authorization for registration and marketing, it needs to be considered interchangeable with the reference drug. That is, be considered safe for replacement.
Thus, when issuing the authorization for sale, ANVISA guarantees to the public the purchase of a medicine with the same quality and effectiveness as the brand name.
It is worth mentioning that the exchange should only be made after validation and guidance from specialists.
In case of doubts on this subject, the ideal is that you seek specialized help. Health professionals are always instrumental in assisting and providing reliable information.
In addition, always consult trusted doctors, or pharmacists, to ensure safe drug substitutions and always provide the ideal treatment for you.
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