FDA has postponed the committee meeting for Celltrion’s infliximab biosimilar

February 27, 2015 7:01 AM

The Food and Drug Administration (FDA) announced that, the meeting of the Arthritis Advisory Committee scheduled for March 17, 2015, has been postponed.

The meeting was scheduled to discuss Celltrion’s infliximab biosimilar, Remsima. The product is a biosimilar version of Johnson & Johnson’s Remicade and the submission to the FDA was made in August last year.

Celltrion (with its partner Hospira) had launched the product in Central and Eastern Europe and some smaller Western European markets due to earlier patent expiry. Very recently, the product has been launched in major European markets, Austria, Denmark, France, Germany, Italy, Spain, Netherlands, Sweden.

The committee meeting which will discuss the biosimilar application for CT-P13, submitted by Celltrion, Inc. is postponed due to the pending information requests from the sponsor of the application. A future meeting date will be announced in the Federal Register.

Source: FDA

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