The National Health Surveillance Agency in Brazil, ANVISA, has approved the first biosimilars monoclonal antibody for use in the country.
Leading biosimilars drugmaker Hospira, Inc. announced that its partner Celltrion has received approval for its Remsima (infliximab) for use in Brazil. The drug is the first biological medication approved by ANVISA based on comparability. Brazil’s regulator requires a comparability study because under ANVISA’s Normative Resolution RDC 55/20010, biosimilarity must be proven by direct comparison with the reference biological drug. The study showed similarity between Remsima and Janssen’s Remicade, Remsima’s reference biological product.
ANVISA approved Remsima for the treatment of rheumatoid arthritis (RA), ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn’s disease in adults and children, fistulizing Crohn’s disease (advanced), colitis and ulcerative rectocolitis.
“Biosimilars with comparative data of safety and efficacy are welcome by health professionals and also by the patients who use them. The effectiveness and safety of medications should be the foremost concern of those who manufacture, purchase and prescribe these drugs,” said Valderillo Fejo Azvedo, MD, a rheumatology specialist of the Brazilian Rheumatology Society and coordinator of the Brazilian and Latin American Forum for Biosimilars 2010-2014.
In a Phase III trial consisting of 606 patients, Remsima achieved its primary goal of treatment equivalence with Remicade. According to results, 73.4 percent of patients receiving Remsima achieved a 20 percent or better improvement in RA symptoms, based on the American College of Rheumatology criteria, after 30 weeks of treatment, compared with 69.7 percent for Remicade. According to Hospira, 42.3 percent of patients receiving Remsima achieved a 50 percent or better improvement in RA symptoms after 30 weeks of treatment, compared with 40.6 percent for those receiving Remicade. The company said that Remsima presents a similar safety and tolerance profile to Remicade.
“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,” said Sergio Teixeira, MD, medical director for Hospira Brazil. “We are looking forward to offering patients in Brazil better access to high-quality, effective and more affordable treatment options that can also help alleviate some of Brazil’s rising healthcare costs.”
An application for the drug was submitted by Celltrion. Remsima will be marketed by Hospira exclusively in Brazil. Remsima and Inflectra were approved by the European Medicines Agency (EMA) in 2013 and are available in most European countries. Celltrion and Hospira entered a deal in 2009, surrounding eight biosimilar products. The companies recently expanded their partnership, which now provides Hospira with exclusive rights to distribute biosimilar infliximab in many major markets, including Brazil, Mexico, United States, and many European countries and in Canada.
Source: Hospira, Inc.
Last updated: 6/2/15; 11:00am EST