Celltrion USA, a United States subsidiary of South Korea-based biopharmaceutical company Celltrion, announced on Sunday that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its CT-P47, a biosimilar candidate of the reference product ACTEMRA (tocilizumab).
The BLA submission was based on data from the global Phase III clinical trial aimed at assessing the efficacy, pharmacokinetics, safety, and immunogenicity of CT-P47 compared to the reference product ACTEMRA in subjects with moderate to severe active rheumatoid arthritis with inadequate response to methotrexate up to Week 52.
CT-P47 includes the active ingredient tocilizumab and is a recombinant humanised monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist.
The company is seeking approval of CT-P47 in both intravenous and subcutaneous routes of administration.
Alvotech launches confirmatory study for Entyvio biosimilar
Biocon BIologics unveils new dermatology data at EADV Congress 2024
Nektar Therapeutics showcases rezpegaldesleukin at EADV 2024
UCB and Biogen report positive Phase 3 results for dapirolizumab pegol in SLE
Priovant Therapeutics enrols first patients in brepocitinib CLARITY study
AstraZeneca's Fasenra recommended for EU approval in EGPA
Sareum Holdings secures patent allowance for SDC-1801 in China
Kine Sciences reports first patient dosed in KINE-101 Phase 1b/2a clinical study
Carisma and Moderna expand collaboration
Aisa Pharma receives orphan drug designation from FDA for AISA-021(cilnidipine)