First Infliximab Biosimilar Approved in Brazil For Crohn’s Disease

First Infliximab Biosimilar Approved in Brazil For Crohn’s Disease
The National Health Surveillance Agency (ANVISA) in Brazil has approved the commercialization of Remsima (infliximab), indicated for a series of conditions such as Crohn's disease and ulcerative colitis, making it the first biosimilar monoclonal antibody approved in the country. Remsima will be commercialized by Hospira, which will work in partnership with Celltrion. Remsima received the approval from ANVISA to treat Crohn's disease in adults and children, fistulizing Crohn's disease (advanced), colitis, ulcerative rectocolitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis and psoriatic arthritis. ANVISA has approved remsima based on comparability, making it the first biological medication to be approved in Brazil in this manner. "Biosimilars with comparative data of safety and efficacy are welcome by health professionals and also by the patients who use them," explained the coordinator of the Brazilian and Latin American Forum for Biosimilars 2010-2014, Valderilio Feijo Azevedo, MD. "The effectiveness and safety of medications should be the foremost concern of those who manufacture, purchase and prescribe these drugs." In order to receive approval, the company presented results from a comparability study that was analyzed according to ANVISA's Normative Resolution RDC
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