Celltrion Submits Biologics License Application for Avastin Biosimilar to US FDA

[Asia Economy Reporter Minji Lee] Celltrion announced on the 1st that it has applied for marketing approval of the Avastin biosimilar CT-P16 to the U.S. Food and Drug Administration (FDA).

The company stated, "The purpose of the clinical trial is a Phase 3 clinical study comparing the efficacy and safety of CT-P16 and Avastin as a first-line treatment for metastatic or recurrent non-small cell lung cancer," and added, "We plan to apply for approval in each country through continuous discussions with global regulatory agencies."

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