April 19, 2024

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[THE INVESTOR] Celltrion said on May 30 that it has resubmitted its application to gain marketing authorization from the US Food and Drug Administration for Truxima, its copy version of Roche’s blockbuster cancer drug Rituxan to get a nod before the year-end.

The biopharmaceutical company also plans to resubmit an application for the approval of Herzuma, its biosimilar of Roche’s breast cancer therapy Herceptin in June.

“In accordance with the FDA regulations, approval is typically finalized within six months from resubmission, so Celltrion expects approval for the two proposed biosmilars in the US within this year,” the company said in a statement.

The second attempt comes after Celltrion announced in April that the FDA turned down its Biologics License Applications for Truxima and Herzuma, due to production facility and manufacturing process issues. The delay thwarted its plans to win marketing authorization before June this year.

The regulatory setbacks have stemmed from a manufacturing site in Incheon where the FDA found “significant violation” of current good manufacturing practice, or cGMP, regulations for finished pharmaceuticals, while conducting inspections in May last year.

Celltrion said it has made progress addressing the concerns that were raised. “The FDA has recently notified Celltion of its re-inspection schedule regarding the cGMP regular audit results, and separately from this procedure, it has confirmed the resumption of the review procedure for the two proposed biosimlars upon the resubmission of BLAs,” the company said.

Truxima and Herzuma were granted EU approval in 2017 and 2018, respectively.

By Park Han-na (hnpark@heraldcorp.com)