The FDA’s Arthritis Advisory Committee voted 21 to 3 on Tuesday to recommend approval for Celltrion and Pfizer’s biosimilar version of Remicade (infliximab, Janssen Biotech).
A decision by the agency is expected in April.
The follow-on biologic, known as CT-P13, would be the second biosimilar cleared for marketing in the United States after Sandoz’s Zarxio (filgrastim) was approved last March.
Based on the biological similarity of the