Celltrion’s application is based on data from a phase 3 trial of patients with rheumatoid arthritis comparing its biosimilar with Actemra.
Celltrion USA has completed its biologic license application to the FDA for CT-P47, a biosimilar of Genentech’s Actemra (tocilizumab).
The BLA submission was based on data from the global phase 3 clinical trial designed to evaluate the efficacy, pharmacokinetics, safety, and immunogenicity of CT-P47 compared with Actemra in patients with moderate-to-severe active rheumatoid arthritis with inadequate response to methotrexate.
CT-P47 is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Celltrion is seeking approval for CT-P47 in both intravenous and subcutaneous routes of administration.
Actemra is indicated for several indications, including moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis. Actemra is available as both an intravenous infusion and as a subcutaneous solution.
The average monthly cost of Actemra for rheumatoid arthritis administered via intravenous (IV) injection ranges between approximately $2,308 and $4,616, depending on which dose a person receives (4 mg/kg or 8 mg/kg, according to a Genentech spokesperson. The average monthly cost of Actemra for rheumatoid arthritis administered subcutaneously ranges between approximately $2,478 and $4,956 depending on how frequently a person takes it, the dose varies depending on the person’s weight.
In October 2023, the FDA approved Biogen’s Tofidence (tocilizumab-bavi) as first biosimilar to reference Actemra. Developed by Bio-Thera, Tofidence will be commercialized by Biogen in the United States. It has not yet launched, however.
A Biogen spokesperson said the company is evaluating the potential launch timeline for Tofidence in the United States. "We will communicate our anticipated launch timeline with key stakeholders in the future and look forward to bringing this additional treatment alternative to patients," the spokesperson said.