FDA accepts application for proposed biosimilar to Rituxan
The FDA has accepted a biologics license application for Celltrion Inc. and Teva’s CT-P10, a proposed biosimilar to Rituxan, for the treatment of rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, according to a company press release.
“As the global leader in biosimilars who brought Inflectra, the world’s first [monoclonal antibody] 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, chief executive officer of Celltrion, said in the release. “CT-P10, which has been approved in the [European Union] E.U., 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 health care costs. I am hopeful that CT-P10 will bring similar benefits to the [United States] U.S. when approved.”
The application for CT-P10 included data from more than 600 patients and 104 weeks. According to the release, FDA regulatory action is expected in the first quarter of 2018.