Legal requirements on equivalence studies for generics in Brazil

Generics/Research | Posted 02/07/2021 post-comment0 Post your comment

The creation of the legal system for generic medicines began with the introduction of Law Number 9787 in February 1999 (Brazil 1999). According to the National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA), the approval of medicines aims to improve the Brazilian population's access to better, safe and quality medicines at lower prices.

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In order to market generic medicines in Brazil, ANVISA requires pharmaceutical equivalence studies and relative bioavailability/bioequivalence studies.

Pharmaceutical equivalence studies are conducted in laboratories (physicochemical and/or microbiology) in order to certify that two medicines contain identical amounts of the same active ingredient, have the same dosage and route of administration. For this, the two drugs must comply with the standards of the Brazilian Pharmacopoeia or other official compendia authorized by ANVISA. In these studies, the following parameters are generally evaluated: physical appearance, route of administration, viscosity, density, weight or volume and, where applicable, comparative dissolution profile.

To determine bioequivalence, the following parameters are assessed:

  1. Maximum drug concentration (Cmax)
  2. Time to reach Cmax
  3. Area under the plasma concentration curve of a drug vs time (AUC)

Two drugs are considered bioequivalent if the average bioavailability (ASCO-t test/ASCO-t reference and Cmax test/Cmax reference) of the test formulation is between 80% and 125% of the reference formulation, considering a 90% confidence interval, according to the technical regulation for generic drugs approved by ANVISA on 23 May 2003 [1].
Editor’s comment
Readers interested to learn more about regulatory requirements for generics are invited to visit to view the following manuscript published in GaBI Journal:

Regulatory requirements for the acceptance of foreign comparator products in the participants of the International Generic Drug Regulators Programme

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1. Nardi EP, Silva ARA. A closer look at generic drugs: the brazilian case. In: Lowell T. Duncan (Ed). Advances in Health and Disease. Volume 21. Nova Science Publishers; 2020. Chapter 2. ISBN: 978-1-53617-783-1.

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