Background Analysis: US FDA Advisory Committee to Review Celltrion’s Proposed Biosimilar to Remicade– MAR 17, 2015 (AAC)

The US FDA has scheduled a meeting of the Arthritis Advisory Committee (AAC) for Tuesday, March 17, 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.

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