FDA Will Review Application Seeking Approval of Truxima for Same Indications as Rituxan

FDA Will Review Application Seeking Approval of Truxima for Same Indications as Rituxan

The U.S. Food and Drug Administration has accepted for review the biologics license application (BLA) requesting the approval of Truxima (CT-P10), a biosimilar to Rituxan (rituximab), for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis, and microscopic polyangiitis. The FDA’s decision is expected to be released by April 2018.

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 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.

“CT-P10, which has been approved in the EU, 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,” Kee added.

As part of the BLA, data for Truxima is accompanied with that of Rituxan for efficacy, safety, immunogenicity (i.e., its ability to induce an immune response in the body), pharmacodynamics (PD) and pharmacokinetics (PK), results previously obtained from worldwide clinical trials. Truxima was approved by the European Commission in February 2017 and is available in the U.K., Germany, Netherlands, Spain, and the Republic of Korea.

“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, 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.”

The joint agreement for commercialization of Truxima was established between Celltrion and Teva in October 2016. Celltrion is responsible for completing all clinical development and regulatory activities, and Teva will handle all commercial activities in the U.S. and Canada.


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