Setback for Celltrion as FDA sends Complete Response Letter

6 April 2018

Following warnings from the US Food and Drug Administration last year, and again in February, related to its manufacturing practices, South Korean drugmaker Celltrion (Kosdaq: 068270) has now been handed a Complete Response Letter from the agency related to two of its proposed biosimilars.

The rebuff for CT-P10, referencing Rituxan, and CT-P6, referencing Herceptin, was not entirely unexpected, as the firm’s development partner Teva Pharmaceutical Industries (NYSE: TEVA) told investors at the time that the issues could result in the approvals being delayed.

In a statement, Celltrion said the FDA wanted more info about the products, and that it would work closely with the regulator to address the problems, adding it expected approval to go ahead this year.

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