Teva Canada Announces the Approval of TRUXIMA, the first biosimilar to RITUXAN in Canada for the Treatment of Non-Hodgkin's Lymphoma

Teva Canada Innovation, G.P.-.S.E.N.C. announces that Health Canada has granted a notice of compliance (NOC)¹ for TRUXIMA™ (rituximab), the first biosimilar to RITUXAN®² (rituximab) in Canada for the treatment of adult patients in: Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL) and Rheumatoid Arthritis (RA).

"Biosimilars are a new chapter in the therapeutic oncology setting in Canada and represent a growing focus for Teva since they will allow us to increase access to important therapeutic options," said Christine Poulin, Senior Vice President and General Manager of Teva Canada. "Moreover, Teva's biosimilars will have the potential to reduce costs by providing lower-cost treatment options for patients."

First approved in South Korea in November 2016, TRUXIMA™ was approved by regulatory authorities including the European Commission in 2017 and the Food and Drug Administration (FDA) in 2018 for certain indication in the U.S. This announcement establishes Teva's position in the biosimilars space and leverages its existing expertise in the oncology market.

The Health Canada NOC issued to TRUXIMA™ 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 TRUXIMA™ and RITUXAN® are highly similar and there were no clinically meaningful differences in safety and efficacy between TRUXIMA™ and RITUXAN® for the approved indications. TRUXIMA™ is administered via intravenous infusion in varying doses depending on the approved indication.

"For years Teva has been helping millions of Canadians have access to specialty and generic medicines, and now we are proud to be at the forefront of this new era in Canadian health care," concluded Ms. Poulin.

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