Background Analysis: US FDA Advisory Committee to Review Celltrion’s Proposed Biosimilar to Remicade– FEB 9, 2016 (AAC)

The US FDA has scheduled a meeting of the Arthritis Advisory Committee (AAC) for Tuesday, February 9, 2015. The Committee will discuss a biologics license application (BLA) for Remsima (CT- P13), a proposed biosimilar to Janssen Biotech Inc.'s Remicade (infliximab). Janssen is a pharmaceutical company of Johnson & Johnson, and the companies share 50% of their sales of Remicade under an agreement with Merck & Co.

The BLA for Remsima (BLA No. 125544) was submitted by Celltrion, Inc. (Celltrion), a Korean company. Hospira obtained the rights for CT-P13 from Celltrion for marketing in Europe and certain Commonwealth of Independent States countries, the United States, Canada, Australia and New Zealand. Pfizer has announced plans to acquire Hospira.

See the SAC Tracker report