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ARTICLE | Clinical News

Celltrion NDA for rituxan biosimilar awaits FDA panel discussion

September 14, 2018 7:32 PM UTC

FDA's Oncologic Drugs Advisory Committee will meet on Oct. 10 to review a resubmitted BLA for CT-P10 from Celltrion Inc. (KRX:068270), the company's biosimilar of Rituxan/MabThera rituximab.

Celltrion resubmitted the BLA in May, two months after it received complete response letters for CT-P10 and CT-P6, its biosimilar of Herceptin trastuzumab. 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")...

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