Celltrion, Inc. (KRX:068270) today announced 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 Rituxan®1 (rituximab), for discussion by the Oncologic Drugs Advisory Committee (ODAC) on October 10, 2018. Rituxan® is a Biogen and Genentech USA, Inc.’s rituximab product.
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.
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