Celltrion said Thursday that the U.S. Oncologic Drug Advisory Committee (ODAC) unanimously recommended Truxima, Celltrion's Rituxan biosimilar, for Food and Drug Administration (FDA)’s approval.
Truxima, the first biosimilar rituximab medication approved by European Medicines Agency (EMA) in February 2017, is a biosimilar that treats people with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.
ODAC is an independent advisory body that provides FDA with comprehensive opinions on the quality, safety, and economics of medicines under consideration. The committee’s decision is an essential reference point for the FDA's decision to approve a drug. With the recommendation, Celltrion expects to win approval for Truxima in the U.S. by the end of this year.
The committee based its recommendation on the review of a comprehensive data package, including foundational analytical biosimilarity, nonclinical and safety data, as well as clinical pharmacology, immunogenicity, and clinical efficacy.
The results of the clinical development program for Truxima demonstrated that there were no clinically meaningful differences between Truxima and Rituxan regarding the safety, purity and potency of the product for the three proposed indications, Celltrion said.
“We welcome the ODCA’s recommendation,” Celltrion CEO Kee Woo-sung said. “If approved by the FDA, Truxima will be the first rituximab biosimilar to be approved in the U.S. for the three proposed indications.”
The development of biosimilars is of great importance in the field of oncology, and has the potential to increase accessibility to therapies for patients, Kee added.
Teva Pharmaceutical, Celltrion’s U.S. partner for Truxima, also showed enthusiasm about the unanimous recommendation.
“If approved, Teva is well positioned to successfully commercialize Truxima, given our unique portfolio of branded and generic medications, as well as patient support experience,” said Brendan O’Grady, executive vice president and head of North America Commercial at Teva. “We are encouraged by the outcome of today’s meeting, which emphasizes the growing importance of biosimilars and the potential value to be introduced into our health systems.”