Celltrion seeks FDA approval for Actemra biosimilar

Celltrion's headquarters in Yeonsu-gu, Incheon (Celltrion)

Celltrion has completed its submission of a biologics license application (BLA) to the US Food and Drug Administration for CT-P47, a biosimilar candidate mimicking Roche’s rheumatoid arthritis treatment Actemra (tocilizumab), the company said Monday.

The BLA submission was based on results from the global phase 3 clinical trial involving 471 patients. In the clinical trial, the company tested the efficacy, pharmacokinetics, safety, and immunogenicity of CT-P47 compared to the reference product Actemra.

The indications that Celltrion has applied to the FDA for CT-P47 include moderate to severe rheumatoid arthritis in adults, as well as juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis.

"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 Celltrion USA CCO Thomas Nusbickel.

"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."

While seeking the FDA’s approval, Celltrion will apply for authorizations in Europe and Canada, the company added. Celltrion also plans to launch subcutaneous and intravenous formulations of CT-P47.

Roche currently provides Actemra in both subcutaneous and intravenous formulations. Actemra, which contains the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 receptor antagonist. The global market for Actemra was sized at $2.8 billion, and around $1.5 billion of revenue came from the US market.

“Celltrion will expand its autoimmune disease portfolio with the launch of CT-P47, in addition to the company’s tumor necrosis factor-alpha inhibitors, such as Remsima and Yuflyma,” an official from Celltrion said.

By Shim Woo-hyun(ws@heraldcorp.com)