ANVISA published, on June 29, 2026, Informative Note No. 1/2026/SEI/GGBIO/DIRE2, updating guidance on the evaluation of comparative pharmacokinetic (PK) studies for biosimilars submitted as supporting evidence for registration and for the approval of Clinical Drug Development Dossiers (DDCMs). 

The main operational change introduced by the Note is the centralization of the evaluation of these studies under the Biological Products Evaluation Office (GPBIO/GGBIO/DIRE2). The measure aims to streamline and integrate the technical analysis of dossier elements, and is aligned with Art. 8 of RDC No. 875/2024, which provides for the possibility of waiving clinical studies and/or comparative clinical evaluation parameters upon compliance with certain conditions.

In this context, pharmacokinetic data assume an even more central role in demonstrating comparability between the biosimilar and its reference biological product.

Submission codes: what changes and what remains

The submission codes remain the same:  

• 10846 – Biological Product – Pharmacokinetic study: used at the time of submission of a biosimilar’s registration dossier, with the protocol to be linked to the main petition (registration process). All PK studies related to the main petition must be included in a single dossier linked to this code.  
• 10900 – Clinical Trials – Comparative pharmacokinetic studies for investigational medicines – Biosimilars – submitted as DDCM: used when the DDCM contains completed comparative PK studies used as supporting evidence for subsequent phases. Submission is made as a secondary petition linked to the DDCM petition. When clinical development is limited to comparative PK studies (relative bioavailability), DDCM submission is not required.  

Complementary evaluation: GPBIO and COPEC

For studies linked to DDCMs, evaluation will be carried out jointly by the GPBIO and the Coordination of Clinical Research in Medicines and Biological Products (COPEC), each acting within its specific competencies. The comparative PK study must be included in the Investigational Medicinal Product Development Plan and in the Investigator’s Brochure for COPEC review. Requirements may be issued by both areas regarding relative bioavailability studies.

Conclusion of the DDCM analysis is contingent on the GPBIO’s final opinion on the comparative PK study. In cases of prioritized review, under the terms of RDC No. 1001/2025, linked to a subject code 10900 petition, COPEC and GPBIO must issue their positions within 45 days from the granting of prioritization. If the applicant has not filed under subject code 10900 by the time prioritization is granted, the deadline for GPBIO’s first response begins counting from the filing date of the subject code 10900 submission. 

Reuse of previously evaluated studies  

When PK studies have already been evaluated by the GPBIO during clinical development, resubmission of the same documentation at the time of registration is not required. It is sufficient to indicate, via the code 10846 submission, the reference number of the previously approved code 10900 dossier.  

Revoked documents  

The Informative Note revokes the following prior documents on the subject:  

• Clarification Note No. 002/2015/GPBIO/GGPBS/SUMED/ANVISA; 
• Technical Note No. 118/2016/GGMED/ANVISA-MS; 
• Q&A document dated March 3, 2017 (validation of binding assays for bioequivalence and pharmacokinetic comparability studies); and 
• Q&A document dated March 14, 2019 (documents for the analysis of comparative pharmacokinetic studies of biological products).  

Documentation for PK studies submitted under codes 10846 and 10900 must follow the respective checklists available at https://consultas.anvisa.gov.br/#/consultadeassuntos/.