FDA approves CT-P10 for treatment of B-cell non-Hodgkin lymphoma
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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recently, Celltrion(and its partner, Teva Pharmaceutical Industries) announced that the U.Sthe FDA(The OncologyDrug(Consulting(the Committee recommended the FDA's approval of CT-P10 for use as part of a single therapy, combination therapy or maintenance therapy to treat B-cell non-Hodgkin's lymphoma (NHL)ct-P10
CT-P10 is a monoclonal antibody for CD20, a biosimilarpharmaceuticalof RituxanIf approved, CT-P10 would be the first rituximab biosimilar approved in the United StatesCT-P10 has been approved as a biosimilar for rituximab in 40 countries, including EU member states and South Koreacommittee's recommendations are based on a review of comprehensive packets, including biosimilar data, non-clinical data, clinical pharmacology, immunogenicity, clinical efficacy and safety dataThe clinical research and development program of CT-P10 has shown that there is no clinical difference in safety, purity, and efficacy between CT-P10 and rituximab in the treatment of the applied indications
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