Brazil advances in follow-on biologicals/biosimilars approvals, trailing Europe

Biosimilars/General | Posted 09/02/2024 post-comment0 Post your comment

Brazil is the fourth-largest market in terms of approved follow-on biological medications worldwide. As of May 2023, Brazil has approved 52 follow-on biological medicines [1] and approximately 30 biological products awaiting testing or already being tested by the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária) [2].

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As of the latest update, ANVISA has surpassed the US in terms of follow-on biologicals/biosimilars approval, trailing only behind Europe. This information was conveyed by Mr Fabrício Carneiro, General Manager of GGBIO*/ANVISA, during the 2nd Workshop on Biologicals and Biosimilars held in Brasilia, Brazil, on 12 and 13 December 2023.

The workshop convened national and international experts in lectures addressing regulatory and technological aspects, such as Good Manufacturing Practices (GMP) certification, quality control, and biological testing.

During the inaugural session, the Director of ANVISA, Meiruze Freitas, acknowledged the challenge of increasing registrations for biological and follow-on biological/biosimilar medicines in Brazil. She emphasized the global nature of these products, highlighting the need for greater convergence with other countries. 

The 2nd Workshop on Biologicals and Biosimilars was participated by Mr Nilton Tojar, General Manager of the US Pharmacopeia for Latin America, industry representatives from Sindusfarma, Bionovis, and research institutate such as Butantan.

On 4 October 2023, ANVISA published Public Consultation No. 1,206/2023 regarding the modification of current requirements for obtaining authorization for the commercialization of follow-on biologicals/biosimilars. If this measure is approved, it has the potential to expand the development capacity of new follow-on biologicals/biosimilars for the Brazilian population, reducing costs for healthcare systems and also contributing to the goals of the Economic and Industrial Health Complex (CEIS) [2].

*GCBIO – General Management of Biological Products, Radiopharmaceuticals, Blood, Tissues, Cells, Organs and Advanced Therapy Products

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1. Cestari de Oliveira SH. Follow-on biologicals/biosimilars approved in Brazil: May 2023 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2023;12(2):67-72. doi:10.5639/gabij.2023.1202.012
2. GaBI Online - Generics and Biosimilars Initiative. Public consultation for the modification of the biosimilars regulation[]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 9]. Available from:

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