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June 19, 2018

Celltrion resubmits marketing approval to FDA for trastuzumab biosimilar

Celltrion¸ a biopharmaceutical company, has completed resubmission to the US FDA to secure its marketing approval for CT-P6, a proposed mAb biosimilar to Herceptin (trastuzumab).

Celltrion¸ a biopharmaceutical company, has resubmitted its market approval for CT-P6, a proposed mAb biosimilar to Herceptin (trastuzumab), to the US Food and Drug Administration (FDA).

Celltrion originally submitted its Biologics License Applications (aBLAs) for CT-P10 and CT-P6 to the FDA in April and May last year.

However, the FDA issued a complete response letter related to the warning letter issued by the agency in January with regard to the manufacturing facility in Incheon, South Korea.

In May, Celltrion completed the resubmission for the approval of CT-P10, a proposed biosimilar to Rituxan (rituximab) last month.

Celltrion expects the approval for the US market of the two proposed biosimilars within this year.

FDA has notified Celltrion of the schedule for its re-inspection regarding regular audit results and has also confirmed the resumption of the review procedure for the two proposed biosimilars upon the resubmission of the aBLAs.

The approval procedure, as per the FDA regulations, is expected to be finalised within six months from the resubmission.

In 2016, Celltrion had entered into an exclusive partnership with Teva Pharmaceutical Industries to commercialise CT-P10 and CT-P6 in the US and Canada.

Under this agreement, Teva is responsible for commercial activities in the US and Canada, pending regulatory approvals for both products while Celltrion is responsible for completing clinical developments, as well as, regulatory activities.

“Celltrion has resubmitted its market approval for CT-P6, a proposed mAb biosimilar to Herceptin (trastuzumab), to the US FDA.”

Herceptin, which is the reference product for CT-P6, is used to treat cancer tumour that either have HER2 overexpression or HER2 gene amplification. Through several global clinical trials, herceptin has demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety.

CT-P6 was approved by the European Commission (EC) in early 2018 and launched in certain parts of Europe.

CT-P10 is a monoclonal antibody (mAb) biosimilar approved by the European Commission (EC) for the treatment of oncology and launched in Europe in 2017.

The reference product for CT-P10 is Rituxan (rituximab). Rituxan is used to treat patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Currently, CT-P10 is pending FDA review and approval.

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