Brazil's ANVISA approves biosimilar interchangeability to expand patient access

Brazil's health regulator, the Agência Nacional de Vigilância Sanitária (ANVISA), issued Technical Note No. 60/2026 confirming that switching between reference biologic medicines and their biosimilars can be done safely and effectively. The decision, based on accumulated scientific evidence and international experience, aims to lower treatment costs and improve access for millions of patients with serious diseases. It is expected to benefit the public health system (SUS) and private health plans, with more than 80 biosimilar products already registered in Brazil.

The move calls for a policy framework similar to that which promoted generic medicines, seeking to build confidence among physicians, health managers, and patients. Officials anticipate that greater biosimilar use will help sustain the SUS and reduce financial barriers to advanced therapies.