Author byline as per print journal: Sílvia Helena Cestari de Oliveira, MSc

Abstract:
In Brazil, a legal framework for approving biosimilars was established in 2010, via the Resolution of the Collegiate Board of Directors (RDC) biosimilars regulations, RDC 55/2010 [1], by the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA).

Submitted: 29 September 2022; Revised: 26 January 2023; Accepted: 27 January 2023; Published online first:9 February 2023

Celltrion’s Remsima (infliximab) was the first biosimilar product approved in Brazil in 2015, by the comparative pathway and extrapolated a monoclonal antibody (mAb) indication for clinical indications outside those included in biopharmaceutical phase III studies (rheumatoid arthritis and ankylosing spondylitis).

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