Brazil’s ANVISA Approves New Regulation for Biosimilar Drug Registration Simplifying the Development Process for Biosimilars

by | May 28, 2024 | Client Alert, Life Sciences, Regulatory

On May 27, ANVISA (Brazilian Health Regulatory Agency) approved a new regulation for the registration of biosimilar drugs, aiming to simplify and expedite their development.

The new regulation introduces a more flexible approach to the requirements for developing biosimilars, allowing for the omission of certain stages and specific studies where technically feasible. This regulatory shift aims to create a more transparent and predictable environment for the pharmaceutical sector.


Key points of the new regulation include:

  1. Flexible Requirements: The regulation permits the safe relaxation of certain requirements, potentially bypassing some steps in the development process, provided technical viability is demonstrated.
  2. Use of International Reference Products: In cases where a reference product is unavailable domestically, the regulation now allows for the use of internationally acquired comparator medicines, given that they meet the necessary technical requirements.


Regulatory Process and Stakeholder Engagement

The new regulation is the culmination of a process that began in 2022 with the publication of Call Notice 15/2022. This initiative gathered valuable information and support for developing biosimilar products through comparability. Following this, ANVISA conducted a Sectoral Dialogue with civil society on July 31, further informing the regulatory process.

This regulation was developed with civil society involvement throughout, including the Call Notice, Sectoral Dialogue, and Public Consultation stages.

International Harmonization

ANVISA seeks to be on of the first regulatory agencies to align its framework with internationally harmonized standards, consistent with the world’s leading regulatory bodies. This new rule is part of a global movement to adapt the regulatory framework for biosimilars

For more detailed information or any specific inquiries, please do not hesitate to contact us.


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