BioCentury
ARTICLE | Clinical News

FDA issues CRLs for Celltrion biosimilars

April 6, 2018 5:09 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, Feb. 9)...