# Brazil biological medicine regulation expansion > Live situation record from CLSTR: https://clstr.news/situations/brazil-biological-medicine-regulation-expansion > Updated: 2026-08-13T21:41:10.000Z. Sources: 2. Developments: 2. 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. ## Timeline ### 2026-08-13: Brazil Chamber of Deputies approves new medication regulations Brazil's Chamber of Deputies Health Commission approved measures to allow the exchange of biologics for biosimilars and expand health insurance coverage for rare disease medications. 2 sources. https://clstr.news/cluster/brazil-chamber-of-deputies-approves-new-medication-regulations ### 2026-07-20: Brazil's ANVISA approves biosimilar interchangeability to expand patient access ANVISA's new technical note backs safe switching between biologics and biosimilars, aiming to cut costs and widen access in Brazil's public and private health systems. 2 sources. https://clstr.news/cluster/brazils-anvisa-approves-biosimilar-interchangeability-to-expand-patient-access --- Cite as: Brazil biological medicine regulation expansion. CLSTR, https://clstr.news/situations/brazil-biological-medicine-regulation-expansion