The choice of December 16 was based on its historical significance, marking the anniversary of the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA) publication of the resolution in 2010, which established the legal framework for approving the marketing of biological and biosimilar products in Brazil [1].

Biosimilars, which are similar to original biological drugs, offer a more affordable alternative for treating a range of diseases. They must meet the same rigorous standards of safety, quality, and efficacy as the reference drugs and can only be manufactured once the original product’s patent expires.

The creation of the National Biosimilar Drug Day originated from Bill 4214/21, introduced by Congressman Pedro Westphalen (PP-RS). The bill gained strong support from Senators Mara Gabrilli (PSD-SP) and Otto Alencar (PSD-BA) and was approved by the Senate in early December 2024.

Biosimilars are becoming an increasingly vital option in Brazil’s healthcare landscape, providing patients with access to more affordable treatments. With this new law, the country reaffirms its commitment to improving access to essential medications and supporting the continued growth of the biosimilars sector.

Associate Professor Valderilio Azevedo, MD, PhD, Msc, a rheumatologist and the President-elect for the Brazilian Society of Rheumatology (Sociedade Brasileira de Reumatologia, SBR), highlighted the priorities regarding biosimilars, including the need for stronger policies on their authorization and integration into public and private healthcare systems, similar to those in Europe. He also called for the establishment of clear guidelines on interchangeability between reference products and biosimilars, as well as urgently needed pricing rules. Dr Azevedo emphasized that the true impact of National Biosimilar Day will depend on public managers and legislators addressing these critical challenges.

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Key facts of biosimilars approval regulation in Brazil

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 4]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-brazil

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