FDA's staffers have favorable view on Celltrion's Remicade biosimilar

On February 9, 2016, the Food and Drug Administration’s Arthritis Advisory Committee is scheduled to hold an advisory hearing on an application for South Korean firm Celltrion’s (Kosdaq: 068270) CT-P13, a biosimilar version of infliximab, currently only available as the branded biologic Remicade from Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech.

According to briefing papers released ahead of the hearing, FDA staff said their review of the data presented, Celltrion’s comparative analytical data for CT-P13 demonstrates that it is highly similar to the reference product (US-licensed Remicade), notwithstanding minor differences in clinically inactive components. The staffers consider Celltrion's supporting data to be sufficient to support its use in rheumatoid arthritis and ankylosing spondylitis.

CT-P13, which is already approved in Europe and some other markets under the trade name Remsima, is partnered with US pharma giant Pfizer (NYSE: PFE). Pfizer acquired rights to the biosimilar along with its $17 billion acquisition last year of Hospira last year.