The Brazilian Health Regulatory Agency (ANVISA) published on 29 June 2026, Informative Note 1/2026/GGBIO, providing clarifications on the evaluation of comparative pharmacokinetic (PK) studies for biosimilar medicines. Under the new guidance, the assessment of comparative PK studies submitted in support of biosimilar registration and for the approval of Clinical Development Dossiers for Medicines (DDCMs) will now be conducted by the Biological Products Assessment Division (GPBIO/GGBIO).
On 11 June 2026, ANVISA published Technical Note 60/2026, updating its position on the interchangeability of biosimilar medicines [1]. This complementary guidance addresses the regulatory criteria under which a biosimilar may be considered interchangeable with its reference product—a key consideration for substitution policies in clinical practice. Taken together, the Informative Note on PK studies and this Technical Note on interchangeability reflect ANVISA's broader effort to refine its biosimilar framework within a single month.
The update aligns with Collegiate Board Resolution (RDC) 875/2024, which establishes the possibility of waiving comparative clinical efficacy studies, provided that certain conditions are met. In this context, the evaluation of PK data assumes an even more critical role in demonstrating comparability between the biosimilar and its respective reference product.
Submission procedures
The Informative Note reinforces that companies should continue using the previously established subject codes for filing these studies. For biosimilar registration, code 10846 – Biological Product – Pharmacokinetic Study should be used. For studies submitted as DDCMs during the clinical research phase, code 10900 – Clinical Trials – Comparative Pharmacokinetic Studies for Biosimilars submitted as DDCM applies.
In cases where PK studies have already been assessed by ANVISA during clinical development, it will not be necessary to resubmit the same documentation at the time of registration. Companies need only inform the previously approved protocol in the product dossier.
For studies linked to DDCMs, the evaluation will be conducted collaboratively between GPBIO and the Clinical Research Coordination for Medicines and Biological Products (COPEC), respecting the competencies of each unit. The Note further clarifies that in cases of prioritised DDCM analysis, both divisions must issue their opinions within 45 days following the prioritisation approval.
Streamlining regulatory assessment
The publication revokes previous documents on the subject, updating the guidelines and avoiding overlapping orientations. With the release of Informative Note 1/2026/GGBIO, ANVISA aims to strengthen the technical assessment of biosimilars and ensure greater agility in regulatory analysis, without compromising the quality, safety and efficacy standards of these medicines.
The initiative reflects the growing maturity of the biosimilar regulatory framework in Brazil and the agency's commitment to aligning its procedures with evolving scientific knowledge and international best practices. By centralising the evaluation of PK data within a specialised division and establishing clear procedural pathways, ANVISA seeks to provide greater predictability for sponsors while maintaining rigorous scientific standards.
The updated guidance is expected to facilitate more efficient biosimilar development programmes in Brazil, potentially accelerating patient access to these important therapeutic options. The clarification regarding the non-duplication of previously assessed PK data also reduces unnecessary regulatory burden on sponsors, allowing them to focus resources on other aspects of the development and registration process.
As biosimilar markets continue to expand globally, regulatory agencies are increasingly refining their approaches to comparability exercises. ANVISA's updated guidance represents a pragmatic step towards balancing scientific rigour with regulatory efficiency, recognising the pivotal role that PK data play in establishing biosimilarity, particularly when clinical efficacy studies may be waived under appropriate circumstances.
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References
1. GaBI Online - Generics and Biosimilars Initiative. ANVISA updates understanding on biosimilar interchangeability [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Aug 20]. Available from: www.gabionline.net/policies-legislation/anvisa-updates-understanding-on-biosimilar-interchangeability
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