Biosimilars approved in Brazil 2022

Category: Pharma News
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Keywords: biologicals, biosimilars, Brazil

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

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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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. 

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