Celltrion USA submits BLA for biosimilar of Actemra

The US subsidiary of South Korea’s Celltrion (Kosdaq: 068270) is the latest to file for US approval of a biosimilar version of Swiss pharma giant Roche’s (ROG: SIX) Actemra (tocilizumab).

The Biologics License Application (BLA) submission to the US Food and Drug Administration for Celltrion’s CT-P47 was based on data from the global Phase III clinical trial designed to evaluate the efficacy, pharmacokinetics, safety, and immunogenicity of CT-P47 compared to the reference product Actemra in patients with moderate to severe active rheumatoid arthritis with inadequate response to methotrexate up to Week 52.

"The submission of CT-P47 for review is an important step toward providing patients with rheumatoid arthritis a more accessible avenue to treatment for conditions that present such a significant disease burden," said Thomas Nusbickel, chief commercial officer at Celltrion USA. "We plan to lead the market by establishing a diverse product lineup in the autoimmune disease market in the US. We will continue to actively cooperate with the FDA's review in an effort to bring this new treatment option to people living with rheumatoid arthritis as soon as possible," he added.