FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

FDA Advisory Committee Will Consider Remicade Biosimilar

Feb. 17, 2015

An FDA advisory committee will meet next month to consider Celltrion’s biosimilar version of Janssen’s Remicade, putting the agency on track to meet a goal of reviewing five biosimilar applications a year.

This will be only the second advisory committee meeting on a biosimilar. Last month, the FDA’s Oncologic Drugs Advisory Committee unanimously recommended the agency approve Sandoz’s bid to produce its own version of Amgen’s Neupogen (filgrastim).

Celltrion’s proposed biosimilar for Remicade (infliximab), which was filed in August, is scheduled for discussion before the Arthritis Advisory Committee on March 17, and experts say the process may not be as easy as it was for filgrastim.

Filgrastim, which helps chemotherapy patients fight infection, had been used by hundreds of thousands of patients in Europe, which helped override any concerns raised in the review of its application.

Though Celltrion already markets infliximab biosimilar in dozens of countries under the name Remsima, it has far fewer patients currently using it since it is only indicated for patients with certain types of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis, according to the FDA. — Jonathon Shacat