On October 10, 2018 Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody (mAb) biosimilar to Rituxan1 (rituximab) for the treatment of adult patients in three proposed indications (Press release, Celltrion, OCT 10, 2018, View Source [SID1234529850]). The proposed indications are: (1) relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma (NHL) as a single agent; (2) previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and (3) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.

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The FDA will take the Committee’s recommendation into consideration before taking action on the Biologics License Application (BLA) for the proposed Rituxan biosimilar.

The Committee based its recommendation on a review of a comprehensive data package inclusive of foundational analytical biosimilarity data, nonclinical data, clinical pharmacology, immunogenicity and clinical efficacy and safety data. The results of the clinical development program for CT-P10 demonstrated that there were no clinically meaningful differences between CT-P10 and Rituxan in terms of the safety, purity and potency of the product for the three proposed indications.

"We welcome the Oncologic Drugs Advisory Committee’s recommendation. If approved by the FDA, CT-P10, a proposed biosimilar to Rituxan, will be the first rituximab biosimilar to be approved in the United States for the three proposed indications," 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 increase accessibility to therapies for patients."

"If approved, Teva is well positioned to successfully commercialize CT-P10, given our unique portfolio of branded and generic medications, as well as patient support experience," said Brendan O’Grady, Executive Vice President and Head of North America Commercial at Teva. "We are encouraged by the outcome of today’s meeting, which emphasizes the growing importance of biosimilars and the potential value to be introduced into our health systems."

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

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 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 was first launched in Europe in 2017. 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.