Brazil’s ANVISA updates its position on biosimilar interchangeability
Brazil's regulator has issued a technical note saying switching between a reference biologic and its biosimilars, or between biosimilars, does not meaningfully change safety, efficacy or immunogenicity when set conditions are met.
Brazil’s health regulator, ANVISA, has revised how it understands interchangeability between biologic medicines. Its Technical Note 60/2026, issued on 11 June 2026, was reported by GaBI Online on 22 July 2026.
The position
ANVISA concludes that switching patients between a reference biologic and a biosimilar, or between biosimilars that share the same reference product, does not meaningfully change safety, efficacy or immunogenicity, provided the approved conditions are followed.
The conditions
- The conditions in the product’s package insert are respected.
- Clinical follow-up of the patient is ensured.
- Traceability mechanisms are in place.
- Pharmacovigilance continues.
The note does not replace the existing rules for registering biosimilars. It clarifies how interchangeability should be understood in practice, and brings Brazil closer to positions already taken by the WHO and the EMA. The report also notes a prescribers’ society emphasising that switching is only appropriate for clinically stable patients.
Source: GaBI Online, 22 July 2026. This is a summary, not regulatory advice.
