Difference between reference, similar and generic medicine

The number of drugs available on the market is large, as well as the types in which they are classified. With that in mind, we decided to help you understand what is the difference between the main types of drugs currently sold in pharmacies and drugstores across the country: reference, generic, similar and interchangeable similar.

What is medicine Reference

The reference medicine is the originator of the formula used by other laboratories years later. For it to be commercialized, its effectiveness, safety and quality must be scientifically proven to Anvisa.

Due to the research time and the money invested in them, the laboratory that develops the drug has a patent that lasts between 10 and 20 years, in addition to exclusivity in commercialization. It is estimated that the development of a new drug costs around 2.6 billion dollars – that’s why the patent expires after a period of time, so that, with the sale of the formula, part of that money invested has a return.

Regarding its packaging, it must always have a trade name (brand). For this reason, the reference medicine can also be known as a branded medicine .

What is Generic Medicine

The generic drug has the same active ingredient, dose, pharmaceutical form, therapeutic indication and is administered through the same route as the reference drug, but without the fancy name.

In other words, the generic must have the same efficacy, safety and quality as the reference drug, proven through studies of bioequivalence and bioavailability to Anvisa. The production of these products can only be carried out after the term of the patent for the reference drug has expired.

Because manufacturers do not need to invest money and time in all phases of clinical and non-clinical research during their development, generic drugs can be up to 35% cheaper than their originators. In addition, this type of medicine, as it cannot have a commercial name, should be marketed only with the name of its active ingredient.

Generic drugs have a yellow stripe on their packaging, where the writing “Generic Medication” is present.

Does generic medication have the same effect as the original? It’s trustable?

Yes. As explained, the generic drug is produced with exactly the same formula that your reference has, and this is proven via studies for Anvisa.

Therefore, as one drug is similar to the other in terms of its efficacy, safety and quality, it can be said that the generic drug has the same effect as its reference drug, as well as being reliable for the same purposes that the other provides. .

What is Similar Medicine

Similar drugs have the same active ingredient as the reference, as well as the same concentration, dosage form, route of administration, dosage and therapeutic indication. However, they can differ in the size and shape of the product, expiration date, packaging, labeling, excipients and vehicle.

Since September 2001, similar drugs need to use, on the packaging, a fancy brand to be marketed, in order not to be confused with generics – which only bear the name of the active ingredient on their packaging.

What is Similar Interchangeable Medicine

Similar interchangeable drugs are those that conformed to RDC nº 134/2003 and submitted to Anvisa comparative studies with the reference drugs until December 2014.

These studies include items such as pharmaceutical equivalence, dissolution profile and relative bioequivalence / bioavailability, if applicable to the drug and pharmaceutical form. That is, through this confirmation, it is possible to find that similar drugs have the same efficacy and effect as their reference and generic drugs.

This situation occurred because, since the implementation of the generic drugs policy in 1999, important health regulations were established due to the need to regulate the Brazilian pharmaceutical market and, thus, improve the quality assurance, efficacy and safety criteria of all medicines marketed in the country.

Attention!
As much as the tests of all similar products were delivered to Anvisa until December 2014, not all of them have been evaluated and approved yet. As the drugs are being analyzed and approved, they will enter the official list of interchangeable drugs , available on the Anvisa website.

What makes a drug interchangeable?

For a drug to be interchangeable, it is necessary to present the bioequivalence and bioavailability tests to Anvisa – this is true for both generics and similar ones. In certain cases, both studies are not required, in which a laboratory analysis ( in vitro ) replaces the test in living beings ( in vivo ). Thus, bioisention is characterized.

The purpose of these analyzes is to prove the equality of the products in relation to their reference medicine.

Bioequivalence (BQV)

This analysis aims to demonstrate pharmaceutical equivalence between products presented in the same pharmaceutical form, with the same qualitative and quantitative composition of the active ingredient.

Bioavailability

Bioavailability indicates the speed and extent of absorption of the active principle in a dosage form, through the concentration / time curve in the systemic circulation or excretion in the urine.

Bioisention

Some criteria were adopted in view of the exemption from bioequivalence and bioavailability studies, considering the pharmaceutical form, dosage, solubility and route of administration.

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