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FDA’s Arthritis Advisory Committee Recommends Approval of Celltrion’s CT-P13, a Proposed Biosimilar Infliximab, for All Eligible Indications
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The Committee based its recommendation on the totality of evidence presented at the Arthritis Advisory Committee meeting, comparing CT-P13 to the U.S. reference product, Remicade®, in which the Committee concluded that the data submitted by Celltrion demonstrates CT-P13 is highly similar to U.S.-licensed Remicade®, notwithstanding minor differences in clinically inactive components. Further, the Committee noted that there were no clinically meaningful differences between CT-P13 and U.S.-licensed Remicade® in terms of the safety, purity, and potency of the product in the studied indications of rheumatoid arthritis and ankylosing spondylitis. The Committee acknowledged the extensive data provided by Celltrion to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use.
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Feb 10, 2016
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Related Keywords Remicade, Biosimilar, Remsima, Rheumatoid Arthritis, Crohn's Disease, Inflammatory Bowel Conditions, Ct-p13, Infliximab