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FDA to Review Teva and Celltrion’s BLA for Proposed Biosimilar to Herceptin

13:20 EDT 31 Jul 2017 | Speciality Pharma Journal

ev INCHEON, Republic of Korea & JERUSALEM–(BUSINESS WIRE)–Jul. 31, 2017– Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for CT-P6, a proposed Monoclonal Antibody (mAb) biosimilar to Herceptin®1 (INN: trastuzumab) which is used for the treatment of Human Epidermal growth factor Receptor 2 …

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