EC approves first biosimilar mAb

The European Commission approved the first biosimilar mAb -- Inflectra/ Remsima infliximab from Celltrion Inc. (KOSDAQ:068270) and partner Hospira Inc. (NYSE:HSP) to treat multiple inflammatory conditions. Hospira plans to start launching the biosimilar of autoimmune drug Remicade infliximab "in the coming months" (see BioCentury Extra, June 28).

Celltrion and Hospira are required to implement a risk-management plan to confirm the long-term efficacy and safety of the biosimilar. The partners also must implement a pharmacovigilance plan. ...