FDA to Review Application Seeking Truxima Approval for Same Indications as Rituxan

The U.S. Food and Drug Administration (FDA) has accepted for review the biologics license application  seeking approval of Truxima (CT-P10), Celltrion‘s biosimilar to Rituxan (rituximab), for the same indications as Rituxan.

The FDA’s decision is expected by the first quarter of 2018. If approved, Truxima will become available for two ANCA-associated vasculitis (AAVs), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). In addition to those ANCA- (anti-neutrophil cytoplasmic antibodies)-related conditions, the application for Truxima includes non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and rheumatoid arthritis (RA).

Biosimilars are biological medical products that are nearly identical to the original product, but manufactured by a different company after the original product’s patent expires. They usually are sold at significantly lower prices.

“As the global leader in biosimilars who brought Inflectra, the world’s first mAb [monoclonal antibody] biosimilar approved by the FDA, to the U.S., we are pleased and honored to have this opportunity to once again work with the FDA on CT-P10,” Woo Sung Kee, CEO, of Celltrion, said in a press release.

Truxima is an investigational antibody designed based on the structure and activity of Rituxan, a reference medicine already approved by the European Commission and FDA. It specifically targets the surface protein CD20, expressed by the majority of immune B-cells, showing potential in certain blood cancers and in several autoimmune diseases, such as rheumatoid arthritis and GPA.

The recent application is supported by preclinical and clinical results showing that the effectiveness, safety, and ability to generate an immune response of Truxima is not inferior to that of Rituxan. These studies included more than 600 patients.

Truxima was approved in the European Union in February 2017, and is commercially available in the U.K., Germany, Netherlands, Spain, and the Republic of Korea.

“CT-P10 [Truxima] … is continuing to build a solid track record since its launch there earlier this year and has provided patients with access to a high quality treatment option and has offered great savings in healthcare costs. I am hopeful that CT-P10 will bring similar benefits to the U.S. when approved,” said Sung Kee.

Under the collaborative agreement established between Celltrion and Teva in October 2016, Celltrion is responsible for completing all clinical development and regulatory activities of Truxima, while Teva will be responsible for all commercial activities in the U.S. and Canada.

“Teva is pleased to announce this important milestone today, with our partner Celltrion, bringing us one step closer to making additional biosimilar treatment options available to patients in the U.S.,” said Paul Rittman, senior vice president and general manager at Teva Oncology.

“We look forward to leveraging Teva’s unique cross-functional capabilities across both specialty and generic medicines to continue our commitment to serving those dealing with cancer, rheumatoid arthritis, and other serious diseases,” Rittman added.