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FDA approves Celltrion's Herceptin biosimilar

December 14, 2018 11:39 PM UTC

FDA approved a BLA for Herceptin biosimilar Herzuma trastuzumab-pkrb from Celltrion Inc. (KOSDAQ:068270) to treat HER2-positive breast cancer.

In April, Celltrion received complete response letters from FDA for Herzuma and Truxima rituximab-abbs, its Rituxan biosimilar. Celltrion said at the time the letters were directly related to FDA's January warning letter describing GMP violations observed during a visit to Celltrion's manufacturing facility (see "FDA Issues CRLs for Celltrion Biosimilars")...