Celltrion and Teva Announce FDA Approval of Truxima, a Biosimilar to Rituxan, for Three Non-Hodgkin's Lymphoma Indications
6 December 2018 - - The US Food and Drug Administration has approved Truxima (rituximab-abbs), a monoclonal antibody biosimilar to Rituxan (rituximab) for the treatment of adult patients in three indications, South Korean biopharmaceutical company Celltrion, Inc. (KRX: 068270) and Israeli generic drug specialist Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) said.

Those indications include relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non–Hodgkin's lymphoma as a single agent.

Also, Truxima was approved for 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.

Truxima was approved for 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 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.

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 US 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.

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.