Ana Cecilia Amado Xavier de Oliveira

Berg MJ

Bialer M

Birkett DJ

Borgherini G

Corrao G

Davit B

Duerden MG

Formenti L

Francisco José Roma Paumgartten

Galgatte UC

Gidal BE

Godman B

Henney JE

Kesselheim AS

Mendes P

Midha KK

Peterson GM

Privitera MD

Soinska-Schneider A

Yamada M

Ciência & Saúde Coletiva

Abstract Since the enforcement of Generics Act (1999), three types of pharmaceutically equivalent products are marketed in Brazil: innovative reference (REF), “similar” (S) and generic (G) drugs. The S (brand name) and G (generic name) borrow from REF (brand name) clinical data on safety and efficacy and dosage regimen. G (but not S) is bioequivalent to and interchangeable with REF. Starting in 2003, Brazilian Sanitary Surveillance Agency (Anvisa) has required data on relative bioavailability tests (with REF) to approve (or renew registration of) S drugs. In 2014, Anvisa extended interchangeability notion to similar drugs with a “comparable” bioavailability, i.e., an “equivalent” similar drug (EQ). Drugs for chronic diseases and “critical dose medicines” are listed among the EQ drugs approved. Interchangeability of nonbioequivalent medicines raises deep concerns regarding therapeutic failures and adverse events. Concerns are even more worrisome if patients switch from one drug to another during an ongoing treatment for illnesses such as epilepsy, congestive heart failure, hypertension, diabetes and/or substitutable drugs have a narrow therapeutic index.</jats:p

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Nonbioequivalent prescription drug interchangeability, concerns on patient safety and drug market dynamics in Brazil

Nonbioequivalent prescription drug interchangeability, concerns on patient safety and drug market dynamics in Brazil

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