Search results for Brazil

Economic feasibility of ‘Pay One Price’: an analysis of three biosimilar molecules with different prices and indicated for rheumatoid arthritis in a medium size HMO 

Introduction/Objective: To evaluate the economic feasibility of a uniform ‘Pay One Price’ (POP) pricing model for three tumour necrosis factor (TNF) inhibitor biosimilars (adalimumab, infliximab, etanercept) used in rheumatoid arthritis (RA) treatment within a Brazilian medium-sized health maintenance organization (HMO). Methods: Medication prices were obtained from Brazil’s Chamber for the Regulation of the Medicines Market (CMED). […]

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Follow-on biologicals/biosimilars approved in Brazil: September 2025 update

Abstract: In Brazil, the legal framework for approving biosimilars was established in 2010 and the first biosimilar product was approved in 2015. In June 2024, RDC 875 introduced new provisions, including the use of international reference drugs and the possibility of waiving non-clinical and comparative clinical studies under certain conditions. By September 2025, ANVISA had […]

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

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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