In June 2026, the Brazilian Health Regulatory Agency published Technical Note No. 60/2026, a document that updates the national regulatory stance on the substitution of biosimilars for their respective biological comparators.
The publication represents a milestone for the biotechnology market, with practical implications for the production chain, healthcare service providers, and patients undergoing high-complexity therapy.
What ANVISA understands by interchangeability
The Agency defines this condition as the scientific recognition that two drugs are completely interchangeable, maintaining the expectation of the same clinical and safety outcome.
Technical Note No. 60/2026 authorizes alternation both between the biological comparator and its respective biosimilar, and between biosimilars that share the same reference product, provided that the approved guidelines for use are observed.
The scientific and regulatory foundations of positioning
To establish this guideline, ANVISA analyzed data accumulated by partner international agencies and formal recommendations from the World Health Organization (WHO).
The Agency's technical staff concluded that biosimilar options deliver identical efficacy and that the treatment transition entails no additional risks of immunogenicity or loss of therapeutic response.
This global alignment provides greater predictability for companies operating in the Brazilian market.
The requirements for switching between medications
To make the replacement feasible safely on a daily basis, ANVISA requires compliance with three pillars:
- Informational transparency: clear communication with the patient and the inclusion of detailed information in the package insert intended for prescribers;
- Sector-specific training: training of medical teams, pharmaceutical teams, and hospital managers on transition protocols; and
- Traceability control: Accurate identification of the medication and the batch dispensed.
Compliance with these rules is a prerequisite for the rotation to be considered in good standing by health inspection agencies.
The Impact on the Pharmaceutical Market
The new understanding strengthens the competitiveness of biosimilars compared to reference therapies. The document is intended to guide the strategic and commercial planning of companies in the sector, impacting their participation in public tenders and negotiations for the adoption of new technologies within the SUS and the supplemental health care ecosystem.
In addition, companies are required to take a proactive approach to pharmacovigilance and the reporting of adverse events, ensuring the post-marketing monitoring of their products.
Is the substitution of biologics for biosimilars authorized in the Brazilian market?
Yes. With the publication of Technical Note No. 60/2026, ANVISA formally authorizes interchangeability between reference biologics and biosimilars, as well as between different biosimilars of the same comparator, provided that the limits set forth in the package insert are observed.
What administrative and operational requirements must industry stakeholders meet?
Regular substitution presupposes transparent communication with the end user, technical instruction of the healthcare professionals responsible for the prescription, and the guarantee of complete traceability of the medicine batch.
Which pharmaceutical business areas need to comply with the new guideline?
The departments of government relations, market intelligence, and pharmacovigilance need to review their business strategies for participating in public tenders and monitoring post-market safety.
Life Sciences and Healthcare
Fialdini Einsfeld Advogados provides regulatory and legal advisory services to pharmaceutical companies, biosimilar manufacturers, clinical trial sponsors, and other stakeholders in the healthcare sector. Our team monitors regulatory updates from ANVISA and CMED to support clients in implementing regulatory strategies that are sound and in compliance with current laws and regulations.
