The generic medication is the one with the same drug (active ingredient), with the same dosage and pharmaceutical form, delivered through the same route and with the same therapeutic indication of the reference medication in the country, having the same security as the reference medication in the country, which may be interchangeable with it. Interchangeability, i.e., the safe replacement of the reference medication by its generic is ensured by bioequivalence tests submitted to the national health surveillance agency of the ministry of health. This interchangeability can only be performed by the pharmacist in charge, by the pharmacy or drugstore and shall be recorded in the prescription.
Similar are drugs are medications with the same drug, same concentration, pharmaceutical form, delivery route, dosage, therapeutic indication and quality of the reference medication. ANVISA published in 2003 the Directors’ Collegiate Resolution - RDC nr. 134/2003, establishing criteria for the adequacy of similar medications already registered and sold in Brazil. The mentioned RDC obliged the similar drugs record holders to submit comparative studies with the reference medication such as pharmaceutical equivalence, dissolution profile and relative bioequivalence/bioavailability (BD/BE), if applicable to the drug and pharmaceutical form.
The purpose of these determinations is proof to the therapeutic equivalence between the similar medication registered and its respective reference medication.
In 2014, through RDC 58/2014, which defined the measures to be adopted with Anvisa for drug registration holders for the interchangeability of similar medications with the reference medication, it was determined the availability at the website of the Agency of the list of similar medications, indicating the reference medications with which they are interchangeable for purposes of consultation by the general population, by health professionals or by any other interested party.
Every interchangeable similar medication on the list will also have, in the package leaflet, information about the interchangeability, as required by RDC 58/2014. Such information will be presented through the sentence: SIMILAR DRUG EQUIVALENT TO THE REFERENCE MEDICATION.
Prati-Donaduzzi has 9 similar drugs already suited to this new legislation.
Usually, they are innovative medications which efficacy, safety and quality have been scientifically proven, as of the registration with the Ministry of Health, through ANVISA. They are medications that are generally for a long time in the market and have a well-known trademark.
The difference is in the package. Only generic drugs contain, on its packaging, just below the name of the active ingredient that identifies them, the phrase “generic medication - law nr. 9,787 from 1999”. In addition, generic medication is identified by a big blue letter “G” printed on a yellow stripe at the bottom of the product packages. It is what is established by resolution RDC nr. 333, from November 19th, 2003.
It is the test performed with the generic drug, in which it must contain the same active ingredient, in the same amount and with the same characteristics than its reference medication. This pharmaceutical equivalence is required by Brazilian law and the tests are carried out “in vitro” (not involving human beings), in quality control laboratories empowered by the national health surveillance agency.
Bioavailability is the amount and rate of absorption of the active ingredient of the medication into the bloodstream. When two drugs have the same bioavailability in the body, its clinical effectiveness is considered comparable.
The bioequivalence test is to demonstrate that the generic medication and its respective reference medication (that for which the clinical research was conducted to prove its efficacy and safety prior to registration) have the same bioavailability in the body. The bioequivalence test ensures that the generic medication is the therapeutic equivalent for the reference medication, i.e., which has the same clinical efficacy and the same safety related to its reference.
It is the substance existing in the formulation of the medication, responsible for its therapeutic effect, i.e., for its action in the body. Also called drug.
Because manufacturers of generic medication do not need to invest in research to develop them, since the formulations are already defined by the reference medications. Another reason for the reduced prices of generics relates to marketing. Its manufacturers do not need to advertise because there is no brand to be announced..
The focus of these actions is inserted between the guidelines of the national drug policy, approved in October 1998, GM Ordinance nr. 3,916/98, an instrument that came to guide all actions of the ministry of health in the area of medications for the public sector. Thus, on February 10th, 1999, with law 9,787, the legal basis were established for the generic medications and attributions of powers to ANVISA (the National Health Surveillance Agency) to regulate the registration conditions and quality control. Until then, there was no generic medication in the country, only branded and similar medications, using the generic name.
- offering to the population better quality medications, safer and more effective, proven through the execution of bioequivalence and pharmaceutical equivalence tests;
- providing lower-priced medications, since the manufacturers of generics do not need to invest in research to develop them or to advertise them;
- cutting prices of reference medications, with the entry of competing medications (generics);
- contributing to the increasing access to medications;
- strengthening the domestic industry;
- changing the behavior of health professionals (prescribers and dispensers);
- providing technology development for industries, and consequently, for the country.
Generics have the same quality of reference medications, since bioequivalence and pharmaceutical equivalence tests are performed, prior to the grant of registration by ANVISA. These tests are carried out in laboratories of institutions such as USP (University of São Paulo), Unicamp (University of Campinas), UFC (Federal University of Ceará), Santa Casa do Rio de Janeiro, among others. Additional information may be obtained at sessions “Bioequivalence Centers” and “Laboratories & Qualified Centers - Pharmaceutical Equivalence”. The person in charge of quality assurance for the medication is the manufacturer. It is incumbent upon ANVISA to monitor the quality assured by the manufacturer and the bioequivalence conditions, through systematic health inspections.
Reference medications and similar medications are sold through a brand name. Generics are sold through the name of the active ingredient and have a yellow stripe with a big letter “G” that read, “Generic Medication - law nr. 9,787 from 1999” printed on the packaging, according to resolution - RDC 333, from November 19th, 2003.
- the anticipation that 35 billion dollars on drug patents expire in coming years;
- the growth of health care costs;
- an aging population, with the increase of chronic diseases, which leads to high public spending on the health sector;
- the dissemination of new and expensive medical technologies and
- a decrease in mortality and an increase in the population’s life expectancy.