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Celltrion Completes Resubmission for Biosimilar Candidate to FDA for Review

Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P10 (rituximab), a proposed mAb biosimilar to Rituxan® .

Additionally, Celltrion plans on making a resubmission for the approval of CT-P6, a proposed biosimilar to Herceptin® in June. In accordance with FDA regulations, the approval procedure will be usually finalized within six months from the resubmission, so Celltrion expects the approval for the U.S. market of the two proposed biosimilars within this year.

Celltrion submitted Biologics License Applications (BLAs) for CT-P10 and CT-P6 to the U.S. FDA in April and May of last year, respectively. However, it received CRLs (complete response letter) from the FDA related to the Warning Letter issued by the FDA in January 2018, regarding the manufacturing facility in Incheon, South Korea.

Celltrion has made progress addressing the concerns raised by the FDA in the Warning Letter and is committed to working with the Agency to fully resolve all outstanding issues with the highest priority and urgency.

FDA has recently notified Celltrion of its re-inspection schedule regarding regular audit results, and separately from this procedure, it has confirmed the resumption of the review procedure for the two proposed biosimilars upon the resubmission of BLAs.

Celltrion official said: “Celltrion is confident that CT-P10 and CT-P6, following the success of REMSIMA® (INFLECTRA® ) around the globe, will be the alternative oncology treatment options for the patients in the U.S. with proven record of quality, efficacy and safety to the reference product at an affordable price.”

Celltrion and Teva Pharmaceutical Industries, Ltd. entered into an exclusive partnership to commercialize CT-P10 and CT-P6 in the U.S. and Canada in October 2016. As part of the agreement, Teva is responsible for all commercial activities in the U.S. and Canada, pending regulatory approvals for both products. Celltrion has responsibility for completing all clinical development and regulatory activities.

About CT-P10

CT-P10 was the world’s first monoclonal antibody (mAb) biosimilar approved by the European Commission (EC) for the treatment of oncology. The EC approved CT-P10 for the same indications as the reference product, based on data demonstrating comparability in terms of quality, efficacy and safety. The reference product for CT-P10 is Rituxan®1 . 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). Rituximab, the active substance in CT-P10, has been designed to bind specifically to the transmembrane protein CD20 found on both malignant and normal B cells. In 2017, CT-P10 was launched in Europe.

About CT-P6

CT-P6 is an anticancer monoclonal antibody (mAb) biosimilar drug used to treat early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. Similarity of CT-P6 to the reference product, Herceptin®2 , was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials. In 2018, CT-P6 was approved by EC and launched in Europe.

About Celltrion, Inc.

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC’s approval for INFLECTRA® and Remsima®, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. For more information, visit www.celltrion.com .

1 Rituxan® is a registered trademark of Biogen and Genentech USA, Inc

2 Herceptin® is a registered trademark of Genentech, Inc

Contact:

Celltrion, Inc.
Gunn Lee, +82 32 850 5168
Gunhyuk.lee@celltrion.com
or
Heewon Park, +82 32 850 5356
Heewon.park@celltrion.com

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