Me-too Products
This article was originally published in SRA
Executive Summary
Brazil cancels registrations due to lack of BE results
Brazil cancels registrations due to lack of BE results
On 6 December 2004, the Brazilian National Health Monitoring Agency, Anvisa, cancelled the registration of 130 ‘me-too’ products because manufacturers failed to present results of bioequivalence (BE) tests for the products, as required by Resolution 134 of 29 May 20031. The list of products, based on 21 drug substances considered to be high-risk by Anvisa, includes anticoagulants and immunosuppressants (used after organ transplantation), and drugs for the treatment of epilepsy, psychiatric and cardiac disorders, hypertension and asthma.
Anvisa has asked manufacturers to present a plan for the recall of their products from pharmacies and wholesalers; they were asked to do so by the first week of January 2005. In addition, the agency has suspended the marketing of me-too products for which manufacturers had submitted partial results of BE tests; the manufacturers have 365 additional days to complete the BE studies2.
Background
Me-too products are ‘copies’ of original registered drugs that have the same active substance, concentration, pharmaceutical form, administration route, posology and therapeutic indication. Anvisa now requires BE studies in order to demonstrate that these products also have the same pharmacokinetic profile. Each drug is administered under controlled conditions to healthy subjects and its absorption rate and speed are evaluated by means of laboratory analysis (usually blood or urine analysis at predetermined times).
These tests have been mandatory for the registration of me-too products since 20033. For those products already on the market, manufacturers were given different terms for compliance to the regulation, based on the risk level of the drug substance4.
MARIA REGINA SHIMIZU
References
1. RDC-304/2004, 6 December 2004, Di�rio Oficial da União, 7 December 2004
2. RDC-303/2004, 6 December 2004, Di�rio Oficial da União, 7 December 2004
3. RDC-133/2003, 29 May 2003, Di�rio Oficial da União, 2 June 2003
4. RDC-134/2003, 29 May 2003, Di�rio Oficial da União, 2 June 2003