FDA reviewers support Celltrion's biosimilar Remicade

February 5, 2016 12:59 PM

1 0

FDA reviewers support Celltrion's biosimilar Remicade

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 ...

Also read: National Cancer Institute Says Researchers Didn’t Quickly Tell FDA After Two Deaths in a Lymphoma Study

Read more

To category page