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|July 31, 2017 8:00 a.m.|
|Celltrion and Teva Announce U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar to Herceptin® (trastuzumab)|
“Following on the heels of our global success with Remsima®2
(Inflectra®3), our infliximab biosimilar, which has brought
affordable and effective biologic treatment to many patients around the
world with proven similarity of quality, efficacy and safety to the
reference product, we are confident to submit a comprehensive package of
quality, nonclinical and clinical data of CT-P6 for
The BLA for CT-P6 includes data for CT-P6 and reference trastuzumab in terms of efficacy, safety, immunogenicity, pharmacodynamics (PD) and pharmacokinetics (PK). These trials were conducted in over 500 patients in 22 countries.
CT-P6 has been approved by the
“As Celltrion’s North American commercial partner for CT-P6 and CT-P10,
a proposed mAb biosimilar to Rituxin®2 (rituximab), we look
forward to the opportunity to leverage Teva’s strong legacy and U.S.
commercial presence in Oncology to bring additional biosimilar treatment
options to patients,” said
The BLAs for both CT-P6 and CT-P10 have been accepted for filing by the
Headquartered in Incheon,
About CT-P6 (A proposed biosimilar trastuzumab)
CT-P6 is being investigated in the US as a proposed biosimilar to
trastuzumab which is a monoclonal antibody (mAb), a protein designed to
recognize and bind to a specific structure or antigen in the body.
Teva's 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-P6 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:
1. Herceptin is a registered trademark of
2. Remsima is a trademark or a registered trademark of
3. Inflectra is a registered trademark of
4. Rituxan is a registered trademark of Biogen.
Teva Pharmaceutical Industries Ltd.