Brazil biological medicine regulation expansion

Brazil is advancing regulatory and legislative measures to expand access to biological medicines and biosimilars. The process began with the health regulator ANVISA issuing Technical Note No. 60/2026, which confirmed that switching between reference biologic medicines and their biosimilars can be done safely and effectively. This decision aims to reduce treatment costs and support both the public health system (SUS) and private health plans.

Following this regulatory move, the Health Commission of the Brazilian Chamber of Deputies approved two legislative proposals. The first proposal seeks to provide legal certainty for the interchangeability of biological medicines and biosimilars across both public and private sectors, provided technical criteria and traceability are maintained. It includes provisions for patient consultation and allows physicians to prevent substitution through justified medical records.

A second legislative proposal aims to expand mandatory coverage by health insurance plans for home-use medications used to treat rare and immunomediated diseases, such as multiple sclerosis and rheumatoid arthritis, provided they meet specific sanitary and medical guidelines.