Anvisa Updates its Understanding on Biosimilar Interchangeability
Technical Note defends the safety of multiple switching between the comparator (reference) biological drug and its biosimilars. This understanding also extends to multiple switches performed between biosimilars of the same comparator biological drug.
On June 11, 2026, it was published Technical Note No. 60/2026, issued by Anvisa through its General Management of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs and Advanced Therapy Products (GGBIO).
By means of this Technical Note, Anvisa established that it is safe to perform multiple switches between a comparator biological drug and its biosimilars, as well as between biosimilars of a comparator biological drug. In order to issue this opinion, Anvisa analysed national and international pharmacovigilance data, highlighting that:
• The European Medicines Agency (EMA) establishes that biosimilars approved in the European Union (EU) are considered interchangeable with the comparator biological medicine and with other biosimilars, including in situations of multiple switching, provided that they share the same comparator biological medicine and are used according to their approved conditions in the package insert;
• Data from the Food and Drug Administration (FDA) showed that biosimilars — with approved interchangeable status or not — meet the same high standard of quality, safety and efficacy as the comparator biological medicine and that the safety and efficacy risks resulting from multiple switching are insignificant.
Based on such data, Anvisa understands that multiple switching is safe and effective provided that such switching is accompanied by:
• Clear and transparent communication to the patient;
• Education and training of healthcare professionals, managers, and decision-makers, through guidelines that address the needs in the transition process, supporting the use of regulated products in clinical practice, according to their approval characteristics;
• Documentation of the change made;
• Guarantee of traceability (unequivocal identification of product and batch);
• Clarity in the package insert information for healthcare professionals.
Why this matters
Although it does not promote substantial changes in the regulatory framework applicable to biological products and their biosimilars – currently governed by RDC 55/2010 and RDC 875/2024 – the Technical Note represents progress from the perspective of public procurement. This is because it objectively mitigates the argument that separate tenders would be necessary for patients already in treatment and for new (naive) patients, by recognizing the safety and efficacy of multiple switches between the comparator biologic and biosimilars.
Furthermore, the document reinforces regulatory predictability and confidence in the healthcare environment by indicating that prescribing healthcare professionals do not need to link the prescription to a specific brand. In practice, this enables the exchange of a comparator biologic for its biosimilar or between biosimilars, provided that there is proper authorization in the prescription, increasing operational flexibility and efficiency in the acquisition and dispensing of these medications in the Unified Health System.
The Life Sciences & Healthcare team at Souto Correa Advogados remains available to answer questions on this topic.