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)...