CHMP recommends approval of Inflectra infliximab biosimilar(Hospira) for Rheumatoid Arthritis
The CHMP has recommended the European Commission approve Inflectra (infliximab biosimilar), from Hospira, for Rheumatoid Arthritis, Inflammatory Bowel Disease and plaque Psoriasis. This is the first monoclonal antibody therapy to reach a positive opinion following review via the EMA biosimilars regulatory pathway.
The recommendation is based on a Phase III randomised, double-blind study in which Inflectra met its primary endpoint of therapeutic equivalence to the reference product. In the study, 73.4% of patients receiving Inflectra achieved a greater than 20% improvement in RA symptoms after 30 weeks of treatment (using the ACR20 scoring system), compared with 69.7% treated with reference infliximab. The safety and tolerability of Inflectra was also demonstrated to be comparable to Remicade.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
2 mins