Celltrion Announces FDA Oncologic Drugs Advisory Committee Meeting Schedule for Proposed Biosimilar to Rituxan® (Rituximab)

On September 12, 2018 Celltrion, Inc. (KRX:068270) reported that the U.S. Food and Drug Administration (FDA) has scheduled the Biologics License Application (BLA) for CT-P10, a proposed monoclonal Antibody (mAb) biosimilar to Rituxan1 (rituximab), for discussion by the Oncologic Drugs Advisory Committee (ODAC) on October 10, 2018 (Press release, Celltrion, SEPT 12, 2018, View Source [SID1234529405]). Rituxan is a Biogen and Genentech USA, Inc.’s rituximab product.

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The ODAC reviews and evaluates data concerning the safety and effectiveness of investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.

"We are fully committed to preparing for this advisory committee meeting and look forward to the discussion about CT-P10," said Woosung Kee, Chief Executive Officer of Celltrion. "The development of biosimilars is of great importance in the field of oncology, and has the potential to enrich our therapeutic arsenal and to increase accessibility to therapies for patients at an affordable price."

Celltrion and Teva Pharmaceutical Industries, Ltd. entered into an exclusive partnership to commercialize CT-P10 in the U.S. and Canada in October 2016.

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

About CT-P10

Celltrion’s CT-P10, a proposed biosimilar to Biogen and Genentech USA, Inc.’s Rituxan, is currently approved in more than 47 countries across the globe. CT-P10 is 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 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