If approved, CT-P10, a proposed biosimilar to Rituxan® (rituximab), will be the first rituximab biosimilar to be approved in the United States
Celltrion, Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced 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 Rituxan®1 (rituximab) for the treatment of adult patients in three proposed indications. 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.
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.
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.
About Celltrion, Inc.
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacturing 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.
Teva Pharmaceutical Industries Ltd. is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.
Teva Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding CT-P10, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:
and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2017, including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
Josh Hwang, +82 32 850 5171
Gunn Lee, +82 32 850 5168
Heewon Park, +82 32 850 5356
Teva Pharmaceutical Industries Ltd.
Kevin C. Mannix, 215-591-8912
Ran Meir, 972 (3) 926-7516
Doris Saltkill, 913-777-3343
Yonatan Beker, 972 (54) 888 5898