ANVISA Approves First Infliximab Biosimilar in Brazil

Hospira has announced that its partner, Celltrion — a global biopharmaceutical company — has received approval from ANVISA — the National Health Surveillance Agency in Brazil — for Remsima (infliximab), the first biosimilar monoclonal antibody approved for use in Brazil. The medication will be marketed by Hospira. Hospira also markets and sells biosimilar infliximab in 26 European countries and in Canada under the brand name Inflectra. This important product has been approved in Brazil 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.

Remsima is the first biological medication approved by Brazil's regulator, ANVISA, based on comparability. A comparability study is required because under ANVISA's Normative Resolution RDC 55/2010, biosimilarity must be proven by direct comparison with the reference biological drug (products must be compared in a single clinical trial and using the same procedures). The study provided evidence of similarity between Remsima and the reference biological product, Remicade (infliximab). 

"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 Valderilio Feijo Azevedo, 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 involving 606 patients, Remsima achieved its main goal of treatment equivalence with Remicade. The trial showed that 73.4% of patients receiving Remsima achieved a 20% or better improvement in rheumatoid arthritis symptoms (based on American College of Rheumatology criteria) after 30 weeks of treatment, compared with 69.7% for Remicade.

During the same trial, 42.3% of patients receiving Remsima achieved a 50% or better improvement in rheumatoid arthritis symptoms (based on American College of Rheumatology criteria) after 30 weeks of treatment, compared with 40.6% for Remicade.  Remsima also 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, 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," continued Teixeira.

Remsima and Inflectra were approved by the European Medicines Agency (EMA) in 2013 and are currently available in most European countries. Celltrion submitted an application to ANVISA to approve Remsima and Hospira will market the product exclusively in Brazil.