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