The US FDA has this week approved Truxima, a monoclonal antibody biosimilar to Rituxan, for treating three non-Hodgkin’s lymphoma indications.
This is an important milestone for Celltrion and Teva Pharmaceuticals who partnered back in October 2016 to commercialise Truxima in the US and Canada.
“The approval of Truxima is a significant milestone for Celltrion and, more notably, for the patients who need access to this important medication,” said Celltrion CEO Woosung Kee.
“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 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 evidence submitted 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.”