Truxima, a monoclonal antibody (mAb), has been approved to treat adult patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non–Hodgkin’s lymphoma (NHL) as a single agent.
Other indications approved included previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy, and patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy.
In addition, Truxima has been approved for non-progressing, low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
Celltrion CEO Woosung Kee said: “The approval of Truxima is a significant milestone for Celltrion and, more notably, for the patients who need access to this important medication.
“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 approval was based on the assessment of a comprehensive data package, including foundational and analytical characterization, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data.
According to the company, the Truxima’s totality of evidence showed that there were no clinically meaningful differences in purity, potency and safety between Truxima and Rituxan for the three indications.
Teva North America commercial head and executive vice president Brendan O’Grady said: “This is an exciting time to be involved in the biosimilars space and we look forward to bringing the product to market.
“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.”
In October 2016, Celltrion and Teva have collaborated to exclusively commercialize Truxima in the US and Canada. Both firms have entered into a settlement agreement with Genentech, including entry terms.
Celltrion is specialized in research, development and manufacturing of biosimilar and novel drugs, while Teva provides generic medicines for select diseases such as CNS, pain and respiratory.