Celltrion submits application for Actemra biosimilar to FDA
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Celltrion USA has submitted a Biologics License Application to the FDA for its tocilizumab biosimilar candidate CT-P47, according to a press release.
Tocilizumab (Actemra, Genentech) is a recombinant humanized monoclonal antibody antagonist to interleukin 6 (IL-6).
The application came in the wake of a phase 3 study comparing the candidate drug with the bio-originator over 52 weeks in a cohort of patients with moderate-to-severe active rheumatoid arthritis who had failed to mount a sufficient response to methotrexate. Efficacy, pharmacokinetics, safety and immunogenicity underwent analysis.
“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,” Thomas Nusbickel, chief commercial officer at Celltrion USA, said in the release. “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.”
Other indications for tocilizumab include juvenile idiopathic arthritis and systemic JIA.
The application requests approval for intravenous and subcutaneous formulations of CT-P47, according to the press release.
The FDA in September approved Tofidence (tocilizumab-bavi, Biogen) as the first tocilizumab biosimilar in the United States for the treatment of RA and other conditions.
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