The National Health Surveillance Agency (ANVISA) in Brazil has approved the use of the monoclonal antibody Remsima (infliximab) from Hospira Inc. and its partner Celltrion.
Remsima is responsible for the treatment of, “rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn’s disease in adults and children, fistulizing Crohn’s disease (advanced), colitis and ulcerative rectocolitis.” This approval was based on a comparability study conducted by ANVISA, which provides evidence that Remsima and the reference drug, Remicade, were similar.
“In a phase III trial involving 606 patients, Remsima achieved its main goal of treatment equivalence with Remicade. The trial showed that 73.4 percent of patients receiving Remsima achieved a 20 percent or better improvement in rheumatoid arthritis symptoms (based on American College of Rheumatology criteria) after 30 weeks of treatment, compared with 69.7 percent for Remicade. During the same trial, 42.3 percent of patients receiving Remsima achieved a 50 percent or better improvement in rheumatoid arthritis symptoms (based on American College of Rheumatology criteria) after 30 weeks of treatment, compared with 40.6 percent for Remicade. Remsima also presents a similar safety and tolerance profile to Remicade.”
Remsima is currently available in many European companies after their approval by the European Medicines Agency in 2013. Hospira holds exclusive rights and responsibilities for Infliximab across many major markets, including the US, Canada, and now Brazil. It also currently has one of the largest selections of biosimilars in the industry along with 7 years of experience distributing the medication.