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FDA reviewers support Celltrion's biosimilar Remicade, ahead of the Ad Comm meeting on February 9

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Additional Information

Additional Relevant Details 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.
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Catalyst Date
Occurred on:
Feb 05, 2016
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Related Keywords Remicade, Biosimilar, Remsima, Rheumatoid Arthritis, Crohn's Disease, Inflammatory Bowel Conditions