South Korean biopharma company Celltrion said Wednesday that it has resubmitted its Rituxan-referencing biosimilar Truxima to the US Food and Drug Administration for a second review, resuming approval procedures that were recently halted due to manufacturing issues observed by the FDA.

Celltrion also plans to resubmit Herzuma -- its biosimilar referencing Herceptin -- to the US FDA in June. As the US regulator’s approval procedures are completed within six month from the date of resubmission, Celltrion said it expects both drugs to earn approval by the year’s end.

The resubmissions were made after the US FDA initially rejected the two proposed biosimilars in April, issuing Complete Response Letters that cited irregularities stipulated in warning letters issued in January.


The warning letters, based on an inspection held from May 22 to June 2, 2017, had raised issues with Celltrion’s manufacturing processes, such as deficient aseptic processing management and a lack of procedures to prevent microbiological contamination at its facilities in Songdo, Incheon.

Celltrion said it has been working closely with the US FDA to address the concerns raised by the warning letters with the “highest priority and urgency.”

And as a result, the FDA recently notified Celltrion of its re-inspection schedule and has confirmed that the review procedures for the two proposed biosimilars would resume upon the resubmissions.

“Celltrion is confident that CT-P10 (Truxima) and CT-P6 (Herzuma), following the success of Remsima (Inflectra) around the globe, will be alternative oncology treatment options for patients in the US with a proven record of quality, efficacy and safety to the reference product and affordable pricing,” the firm said in a statement.

Celltrion has continuously reiterated that the warning letters did not affect its ability to manufacture and supply Remsima -- its Remicade-referencing biosimilar -- citing confidence in the safety and efficacy of products manufactured at its Songdo facilities.

If approved by the FDA, Celltrion’s Truxima and Herzuma will be marketed in the US by its partner Teva Pharmaceutical Industries, which holds the drug’s marketing rights in the US and Canada. Celltrion is responsible for all clinical development and regulatory activities.

The two biosimilars developed by Celltrion have already been approved in the European Union. Truxima was approved in February 2017, while Herzuma was approved in February 2018. Both are currently sold across Europe via Celltrion’s marketing partners.

The Korean drugmaker has been selling its Remicade-referencing biosimilar Remsima, also sold under the name Inflectra, in Europe since 2015 and in the US since October 2016.

By Sohn Ji-young (jys@heraldcorp.com)