CHMP backs first biosimilar mAb

EMA's CHMP backed approval of the first biosimilar mAb on Friday -- a biosimilar from Celltrion Inc. (KOSDAQ:068270) and partner Hospira Inc. (NYSE:HSP) of autoimmune drug Remicade infliximab. Hospira plans to launch the biosimilar as Inflectra in Eastern and Central Europe by year end and said prices for the biosimilar have not been determined. Celltrion -- which will market the product as Remsima in the EU -- could not be reached for details. Celltrion already markets Remsima in South Korea. Hospira has co-exclusive rights from Celltrion to commercialize the biosimilar in the U.S., Canada, EU, Australia and New Zealand.

According to Celltrion, the biosimilar was tested in rheumatoid arthritis and ankylosing spondylitis. CHMP backed approval of Inflectra/Remsima for these indications, as well as for the other indications on Remicade's label, which includes Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis. As part of EMA's biosimilars guidelines, Celltrion and Hospira are required to implement a risk-management plan to confirm the long-term efficacy and safety of the biosimilar. ...