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July 07, 2017
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Although the RDC 55/2010 does not provide information about interchangeability, the Brazilian Sanitary Law states that only chemical drugs registered as reference and as non-branded generic are interchangeable. Therefore, considering that a biosimilar is not an exact replica of the reference new biological product and, hence, cannot be considered as generic of a new biological product, both may not be considered interchangeable.
Regarding this matter, ANVISA recently published a Statement (Nota de Esclarecimento nº 003/2017/GPBIO/GGMED/ANVISA) clarifying that the regulatory pathway for registration of a biosimilar through development by comparability does not require studies demonstrating interchangeability.
This is because the main objective of comparability is to prove that there are no significant differences between the biosimilar and new biological product regarding quality, effectiveness and safety issues.
According to ANVISA, interchangeability is more related to clinical practices and involves broad aspects such as literature data, medical evaluation and issues related to traceability and pharmacovigilance.
Therefore, ANVISA understands that the responsibility for creating policy and guidelines defining the situations in which the substitution of the reference drug by the biosimilar drug must be assigned to the Ministry of Health and doctors that prescribe the drugs.
In any case, ANVISA highlighted that the substitution of a new biological drug (reference drug) by a biosimilar should be always preceded by medical evaluation and also emphasized that the multiple-switches between these drugs are not advisable, inasmuch as it could make traceability and pharmacovigilance difficult.
Please find attached the full version of ANVISA’s recent statement.
Our firm is available to provide further comments on the aforementioned statement and to solve any questions that may come up about the new biological and biosimilar products in Brazil”.