Brazilian health regulator issues Technical Note 60/2026, reinforcing safety of product switching and potential for healthcare cost savings
The Brazilian Health Regulatory Agency (ANVISA) has published Technical Note 60/2026, updating its position on the interchangeability of biosimilar medicines. The document, prepared by the General Office of Biological Products (GGBIO), consolidates scientific evidence and international experience, concluding that switching between biosimilars and their comparator biological products does not significantly alter safety, efficacy, or immunogenicity profiles when performed according to approved usage conditions.
New rules for switching
According to the technical note, a biosimilar is considered highly similar to its reference biological medicine, with no clinically relevant differences between them. The agency now permits switching between the comparator medicine and its biosimilars, as well as between different biosimilars that share the same comparator, provided that:
- The conditions approved in the package insert are respected;
- Clinical follow-up is guaranteed;
- Traceability mechanisms are in place;
- Pharmacovigilance actions are maintained.
This approach aligns with recommendations from the World Health Organization (WHO) and other international reference health authorities, including the European Medicines Agency (EMA), which has emphasized since 2022 that biosimilars approved in Europe are interchangeable from a scientific standpoint.
Regulatory framework
The approval of biosimilars in Brazil follows a rigorous comparability exercise, as established by ANVISA Resolutions RDC 55/2010 [1] and RDC 875/2024 [2]. The new technical note does not replace these regulations but provides additional clarity on how interchangeability should be understood and implemented in clinical practice.
The pricing framework for biosimilars is governed by CMED Resolution No. 3/2025, which recently came into effect. Under this resolution, biosimilars are priced at no more than 80% of the originator biological product's price.
Growing market
Brazil's biosimilar market continues to expand rapidly. By December 2025, the country had 67 active biosimilar registrations [3] with another 52 awaiting approval. Currently, over 90 products are approved, placing Brazil among the top 10 countries globally for biosimilar availability. ANVISA reports an average of 16 new registrations per year since 2019, with 2026 expected to set a record for new product approvals.
Impact on costs and access
The introduction of biosimilars has already generated substantial savings for Brazil's Unified Health System (SUS). According to data from the Ministry of Health's Department of Pharmaceutical Assistance and Strategic Inputs, the acquisition cost for adalimumab 40 mg—an injectable monoclonal antibody used to treat severe chronic inflammatory diseases—fell by approximately 78%, from R848.16 in 2014 to R180 per unit in 2021 following the entry of biosimilar versions.
The industry projects even greater savings ahead. With expanded interchangeability, the sector anticipates potential savings of nearly R500 billion by the end of the decade, potentially reaching R1 trillion. These savings stem not only from lower drug prices but also from reduced hospitalizations and health procedures made possible by broader patient access to treatment.
Clinical considerations
Dr Valderilio Feijó Azevedo, President-elect of the Brazilian Society of Rheumatology (SBR), emphasized that the only contraindication for switching is when the patient is not clinically stable. ‘If the patient is failing [on their current treatment], when you switch to a biosimilar, they will continue to fail, because it is an equivalent product’, he explained. According to Azevedo, the switch is appropriate when the patient is stable and well-controlled on the medication.
For a successful transition, ANVISA requires transparent communication with patients, training for health teams, and the development of clinical protocols. Proper documentation of all changes and robust traceability mechanisms is essential to identify the specific product used in case of adverse events, ensuring continued pharmacovigilance.
Outlook
The updated technical note is expected to provide greater security and clarity for prescribers while encouraging further investment in the biosimilar sector. With clear regulatory guidance now in place and a growing number of products entering the market, biosimilar interchangeability is set to play a central role in expanding patient access and ensuring the financial sustainability of Brazil's healthcare system.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Brazilian guidelines for follow-on biological products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jul 21]. Available from: www.gabionline.net/guidelines/Brazilian-guidelines-for-follow-on-biological-products
2. GaBI Online - Generics and Biosimilars Initiative. New regulations in Brazil for the registration of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Jul 21]. Available from: www.gabionline.net/guidelines/new-regulations-in-brazil-for-the-registration-of-biosimilars
3. Cestari de Oliveira SH, Wassermann GE. Generics and Biosimilars Initiative Journal (GaBI Journal). 2025;14(2).47-52. doi:10.5639/gabij.2025.1402.008
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Source: ANVISA official news release (11 June 2026) and reporting from Futuro da Saúde
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