First infliximab biosimilar, Remsima, approved in Brazil

Generics and biosimilars major Hospira (NYSE: HSP) says its partner, South Korea’s Celltrion (Kosdaq: 068270) 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 drug, a biosimilar of Johnson &Johnson’s (NYSE: JNJ) blockbuster Remicade, will be marketed by Hospira, which 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, according to Hospira.

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).