BioCentury
ARTICLE | Company News

FDA issues CRLs for Celltrion biosimilars

April 5, 2018 11:21 PM UTC

Celltrion Inc. (KOSDAQ:068270) received complete response letters from FDA for BLAs for Herzuma biosimilar trastuzumab (CT-P6) and Truxima biosimilar rituximab (CT-P10).

Celltrion told BioCentury the letters are directly related to FDA's January warning letter describing GMP violations observed at a drug manufacturing facility (see BioCentury Extra, Feb. 8)...

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Celltrion Inc.