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FDA reviewers support Celltrion's biosimilar Remicade
February 5, 2016 / 12:55 PM / in 2 years

FDA reviewers support Celltrion's biosimilar Remicade

Feb 5 (Reuters) - U.S. Food and Drug Administration staff members on Friday said clinical data from Celltrion Inc’s biosimilar form of blockbuster arthritis drug Remicade indicated it is “highly similar” to the branded product in terms of safety, purity and potency.

FDA scientists released their supportive findings ahead of a scheduled meeting on Tuesday of an independent medical advisory panel to the agency, which will weigh whether to recommend approval of the biosimilar, called Remsima, to treat rheumatoid arthritis and inflammatory bowel conditions such as Crohn’s disease.

South Korea’s Celltrion and partner Pfizer Inc want to sell Remsima in the United States as a cut-price copy of Johnson & Johnson and Merck & Co’s branded Remicade, or infliximab, which had global 2014 sales of almost $10 billion. (Reporting by Ransdell Pierson; Editing by Lisa Von Ahn)

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