The Law no 9787/99, which establishes the generic drug in Brazil, states that the bioequivalence is the demonstration of therapeutical equivalence between two drugs holding a comparable bioavailability that are tried under the same experimental design, thus being an indication of the absorption speed and extension of the drug in its dose form. Since 2001, ANVISA has been publishing several Resolutions to establish criteria and requirements to conduct a bioequivalence Trial to register drugs that have been updated along the development of science.
ANVISA Resolution n. 391/1999 – stated bioequivalence requirements.
• In 1999, more than 80% of bioequivalence studies sent to ANVISA were done by international CROs, using an international reference drug product (special registration).
Sponsors that had got market authorization based on special registration must present another bioequivalence study (using a national reference drug product – ANVISA list) at the first registry revalidation (after 5 years).
2000-2001 - Anvisa provided financial support for 09 institutions (universities) to create CROs intended to supply the national demand of bioequivalence studies.
2001 - increased demand for BE studies led to the creation of Coordination of Inspection (CIBIO), responsible for conducting periodical inspections at CROs facilities
ANVISA Resolution n.134/2003 – stated that similar medicines already registered must present BE studies.
– Narrow therapeutic range: until December/2004;
– Antibiotics, antineoplasics and antiretrovirals: until May/2008 (5 years later-first revalidation);
– Others: until May/2013 (10 years later-second revalidation)
Related Journals of Anvisa Bioequivalence
Journal for Clinical Studies, International Journal of BioAnalytical Methods & BioEquivalence Studies, Journal of Bioequivalence & Bioavailability, MOJ Bioequivalence & Bioavailability, Bioanalytical Methods & Bioequivalence Studies, Enliven: Biosimilars and Bioavailablity, Research Journal of Pharmaceutical Sciences, Chemical Speciation & Bioavailability, Journal of Bioanalysis & Biomedicine, Clinical & Experimental Pharmacology, Biochemistry & Pharmacology: Open Access.