FDA Accepts Biologics License Application for Rituximab Biosimilar

The FDA accepted for review the Biologics License Application (BLA) for CT-P10, a proposed biosimilar for rituximab (Rituxan).

CT-P10 is a monoclonal antibody (mAb) designed to target CD20 proteins located on the surface of most B cells. It is a biosimilar to rituximab, which is indicated to treat rheumatoid arthritis (RA), non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis, according to a press release.

“As the global leader in biosimilars who brought Inflectra, the world’s first mAb biosimilar approved by the FDA, to the US, 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 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 health care costs. I am hopeful that CT-P10 will bring similar benefits to the US when approved.”

The BLA contains data from trials examining the safety, efficacy, immunogenicity, pharmacodynamics, and pharmacokinetics of CT-P10 and reference drug rituximab. According to the release, more than 600 patients were included in the trials with up to 104 weeks of data.

In one clinical trial, CT-P10 demonstrated comparable long-term safety and efficacy to reference rituximab in patients with RA who were treated over 48 weeks. No clinically meaningful differences were observed between the groups.

“Our studies consistently demonstrate the equivalence and comparability of our biosimilar rituximab, CT-P10, to reference rituximab,” Dr Kwon Hyuk-chan, medical director of Celltrion Healthcare, said in a release. “We are the only company that is able to proudly state that we have conducted phase 3 clinical trials looking into the safety and efficacy of its biosimilar in 2 indications—–rheumatoid arthritis and non-Hodgkin’s lymphoma––which is a testament to our commitment to providing quality biosimilar treatments for patients supported by robust clinical data.”

The BLA for CT-P10 has been accepted for filing by the FDA for standard review, according to the release. Regulatory Action is expected to occur during the first quarter of 2018.

“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 US,” Paul Rittman, senior vice president and general manager at Teva Oncology, said in a release. “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 European Commission granted approval of CT-P10 in February 2017 and has launched in the UK, Germany, Spain, Netherlands, and the Republic of Korea, according to the release.