Follow-on biologicals/biosimilars approved in Brazil: May 2023 update

Author(s): Sílvia Helena Cestari de Oliveira, MSc

Abstract: Brazilian requirements for approval of biosimilars are aligned with a strict regulatory process and ensure the same high standards of quality, safety and efficacy as for originator biologicals. Submitted: 29 September 2022; Revised: 26 January 2023; Accepted: 27 January 2023; Published online first: 9 February 2023 In Brazil, a legal framework for approving follow-on […]

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