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U.S. FDA Suspended Approvals for Herzuma and Truxima
Celltrion’s Biosimilars
U.S. FDA Suspended Approvals for Herzuma and Truxima
  • By Choi Mun-hee
  • April 6, 2018, 02:30
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The U.S. Food and Drug Administration (FDA) suspended its approvals for Celltrion’s biosimilars Herzuma and Truxima.
The U.S. Food and Drug Administration (FDA) suspended its approvals for Celltrion’s biosimilars Herzuma and Truxima.

 

It has been found that the U.S. Food and Drug Administration (FDA) suspended its approvals for Celltrion’s biosimilars Herzuma and Truxima.

“According to a report from a foreign source, the U.S. FDA recently notified Celltrion of the suspension of the approvals,” said NH Investment & Securities research analyst Ku Wan-sung on March 5, adding, “The approvals are expected to be granted in the fourth quarter of this year or later in view of similar delays of the past.”

Celltrion filed for the approvals in July and June last year, respectively. “Every issue like an adequate Remsima supply in the United States and approvals for Herzuma and Truxima involved response to warning letters,” the research analyst explained, adding, “Delay of the release of Truxima is the only impact on Celltrion’s fundamentals following the delivery of the FDA CRL.”