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Celltrion Completes Resubmission to FDA for Proposed Trastuzumab Biosimilar

Del

Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P6, a proposed mAb biosimilar to Herceptin® (trastuzumab).

Celltrion submitted its abbreviated Biologics License Applications (aBLAs) for CT-P10 and CT-P6 to the FDA in April and May of last year, respectively. However, it received CRLs (complete response letters) from the FDA related to the warning letter issued by the FDA in January 2018, related to the manufacturing facility in Incheon, South Korea.

Celltrion had completed the resubmission for the approval of CT-P10, a proposed biosimilar to Rituxan® (rituximab) last month. 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 calendar year.

FDA has 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 the aBLAs.

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 is responsible for completing all clinical developments and regulatory activities.

About CT-P6

The reference product for CT-P6 is Herceptin® (trastuzumab)1. Herceptin® is used to treat cancer patients whose tumors have either HER2 overexpression or HER2 gene amplification. Similarity of CT-P6 to the reference product, Herceptin®, was demonstrated in terms of pharmacokinetic, pharmacodynamics, efficacy and safety through multiple global clinical trials. CT-P6 is currently pending FDA review and approval. The final U.S. prescribing information for CT-P6 will include the specific uses for which the product is indicated in the U.S. CT-P6 was approved by the European Commission (EC) in early 2018 and launched in certain parts of Europe.

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 and launched in Europe in 2017. The reference product for CT-P10 is Rituxan® (rituximab)2. 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). CT-P10 is currently pending FDA review and approval. The final U.S. prescribing information for CT-P10 will include the specific uses for which the product is indicated in the U.S. 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.

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

Contact information

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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