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FDA rejects Coherus's biosimilar for Amgen's Neulasta
2017年6月12日 / 上午10点55分 / 5 个月前

FDA rejects Coherus's biosimilar for Amgen's Neulasta

June 12 (Reuters) - Coherus BioSciences Inc said on Monday the U.S. Food and Drug Administration denied the approval of its biosimilar for Amgen Inc’s Neulasta, which fights infections in cancer patients.

The FDA’s complete response letter requested for a re-analysis of certain data and asked for additional manufacturing information. (Reporting by Divya Grover in Bengaluru; Editing by Saumyadeb Chakrabarty)

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