Celltrion, a leading biopharmaceutical company based in Incheon, South Korea, announced that the US Food and Drug Administration (FDA) has approved Avtozma (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to Actemra. Avtozma is indicated for the treatment of multiple diseases including rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and coronavirus disease (Covid-19).
""Introducing both IV and SC formulations of Avtozma provides flexibility and a wider range of treatment options,"" said Thomas Nusbickel, chief commercial officer at Celltrion USA. ""This approval represents a strategic addition to our immunology portfolio, further strengthening our commitment to delivering accessible and high-quality treatment options for patients and healthcare providers. Our goal is to provide safe and effective alternatives and ensure appropriate access so plan sponsors can address unique population needs.""
The FDA's decision is based on a comprehensive data package and the totality of evidence, including the results from a phase III study demonstrating biosimilarity between Avtozma and reference tocilizumab in patients with moderate to severe active RA. The primary endpoint was met in terms of change from baseline in disease activity score using 28 joints (DAS28)-ESR at Week 24, and the final 1-year results supported comparability in secondary efficacy, pharmacokinetic (PK), safety and immunogenicity results between Avtozma and reference tocilizumab. The clinical results demonstrated that Avtozma and its reference tocilizumab are highly similar and have no clinically meaningful differences in terms of efficacy, safety, pharmacokinetics (PK) and immunogenicity.
Avtozma will be available in both IV and SC formulations, with the same formulation and dosages as the reference product. The IV infusion is provided as 80 mg/4 mL (20 mg/mL), 200 mg/10 mL (20 mg/mL), 400 mg/20 mL (20 mg/mL) and the SC injection comes in 162 mg/0.9 mL in a single-dose prefilled syringe or single-dose autoinjector.
Avtozma is Celltrion's seventh biosimilar granted marketing authorization in the US.
Avtozma (tocilizumab-anoh), containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global phase III clinical trial designed to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of CT-P47 compared to reference tocilizumab, Avtozma was filed for regulatory approval with the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in January and February 2024, respectively.
Avtozma (tocilizumab-anoh) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of:
Rheumatoid arthritis (RA): Adult patients with moderately to severely active RA who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).
Giant cell arteritis (GCA): Adult patients with GCA.
Polyarticular juvenile idiopathic arthritis (pJIA): Patients 2+ years-old with active pJIA.
Systemic juvenile idiopathic arthritis (sJIA): Patients 2+ years-old with active sJIA.
Covid-19: Hospitalized adult patients with Covid-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide.
