- TRUXIMA is the first rituximab biosimilar to be approved in the United States? INCHEON, South Korea & JERUSALEM--Celltrion, Inc.?(KRX:068270) and?Teva Pharmaceutical Industries Ltd.?(NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved TRUXIMA^?(rituximab-abbs), a monoclonal antibody (mAb) biosimilar to RITUXAN^?[1]?(rituximab) for the treatment of adult patients in three indications:  

• Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non?Hodgkin?s lymphoma (NHL) as a single agent.

 

• ?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.

 

• ?Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

  ?The approval of TRUXIMA is a significant milestone for Celltrion and, more notably, for the patients who need access to this important medication,? said Woosung Kee, Chief Executive Officer of Celltrion. ?TRUXIMA is the very first rituximab biosimilar to be approved in the United States for three non-Hodgkin?s lymphoma indications and may help provide greater accessibility for patients.? The FDA approval is based on a review of a comprehensive data package inclusive of foundational and extensive analytical characterization, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data. The totality of evidence submitted for TRUXIMA demonstrated that there were no clinically meaningful differences in purity, potency and safety between TRUXIMA and RITUXAN for the three indications. ?This is an exciting time to be involved in the biosimilars space and we look forward to bringing the product to market,? said Brendan O?Grady, Executive Vice President and Head of North America Commercial at Teva. ?There is a stronger focus than ever, particularly within oncology, on bringing greater value to the healthcare system through biosimilars increasing the number of treatment options.? Please see the Important Safety Information below including the Boxed Warning regarding fatal infusion reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy. Celltrion and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 to commercialize TRUXIMA in the U.S. and Canada. Teva and Celltrion have reached a settlement agreement with Genentech, including entry terms. The terms and conditions of that agreement are confidential at this time. Important Safety Information