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Celltrion Seeks Okay For A Biosimilar

by Michael McCoy
August 18, 2014 | A version of this story appeared in Volume 92, Issue 33

The South Korean drugmaker Celltrion has filed for FDA approval of a biosimilar version of Remicade, a Johnson & Johnson arthritis treatment that posted close to $7 billion in sales last year. Celltrion says its filing is the first for a monoclonal antibody under the biosimilar approval pathway created in the Biologics Price Competition & Innovation Act of 2009. Last month, Sandoz filed for the first overall such FDA approval for a version of Amgen’s Neupogen, a white-blood-cell-stimulating protein.

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