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 55/2010, having as reference the biological drug. The phase III study, which included 606 participants, revealed the similarity between Remsima and the reference biological product, Remicade (infliximab).
“A robust package of comparative analyses involving Remsima and Remicade showing biosimilar infliximab’s effectiveness and safety during rheumatoid arthritis treatment, as well as supporting data for ankylosing spondylitis, allowed us to extrapolate the data and gain approval from ANVISA to use the biosimilar in treatments for all approved indications of the reference product, without the need for additional clinical trials,” explained the medical director for Hospira Brazil, Sergio Teixeira, MD.
The companies, which have worked together since 2009 following the establishment of a cooperation agreement covering eight biosimilar products, believe that the approval may provide Brazilian patients greater access to more effective and affordable therapies. Remsima was also approved by the European Medicines Agency (EMA) in 2013 and Hospira will market the product exclusively in Brazil.
Hospira is also responsible for the marketing and commercialization of biosimilar infliximab in 26 European countries and in Canada under the brand name Inflectra. Last February, the company announced the launch of Inflectra, in major European markets, also to address several inflammatory conditions such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, adult and pediatric Crohn’s disease, and adult and pediatric ulcerative colitis.
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