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.
- 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.
- 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.