Recently, the Brazilian Health Surveillance Agency (ANVISA) issued, through its Department of Analysis of Biological Products (GPBIO), a memorandum regarding the biosimilar interchangeability of drugs. Biosimilar products are registered drugs that go through a comparability test with a biologically comparable product, which demonstrates that there is no significant difference between those products in terms of quality, effectiveness, and reliability.
Declaring that two products are biosimilar is not the same as declaring they are interchangeable. Interchangeability relates to the possibility of using either one product or another, which has been the main topic of important debates on an international level. GPBIO believes that the regulatory agency should limit its actions to the registration of evidence of biosimilarity, while interchangeability should be a matter decided by doctors and the Ministry of Health, which would require more thorough analysis that encompasses pharmacology and even traceability and pharmacovigilance analyses, including medical evaluation of each specific case.
Since 2015, ANVISA a publishes a Public Report of Drug Acceptance (PPAM) for each drug that is submitted for analysis, which details its essential information regarding quality, effectiveness and reliability. GPBIO believes that eventual studies that evaluate interchangeability might be included in the PPAM, but that does not indicate an official approval of the interchangeability of biosimilar products.
This GBPIO memorandum certainly provides additional clarity regarding ANVISA’s regulatory activities. Due to the vital role this regulatory agency plays in Brazil, it is critical that its reports are transparent and capable of communicating their exact meaning and intention, leaving no margin for dubious interpretation.
GPBIO’s memorandum certainly puts into perspective the position Brazil assumes on this broad international debate. The pharmaceutical industry can now be sure of the real implications regarding ANVISA’s declarations, providing more legal certainty to the declarations of the public administration through its Health Surveillance Agency.
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Read it in pdf: Newsletter – Biosimilares e Intercambialidade