CHMP positive for Avtozma
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Avtozma, intended for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), giant cell arteritis (GCA), CAR-T cell-induced severe or life-threatening cytokine release syndrome (CRS) and coronavirus disease 2019 (COVID-19)
The applicant for this medicinal product is Celltrion Healthcare Hungary Kft.
Avtozma will be available as 20 mg/ml concentrate for solution for infusion and a 162 mg solution for injection in pre-filled syringe or pre-filled pen. The active substance of Avtozma is tocilizumab, an interleukin inhibitor (ATC code: L04AC07). Tocilizumab is a recombinant humanised anti-human interleukin-6 receptor (IL-6R) monoclonal antibody of the immunoglobulin IgG1 subclass. It works by inhibiting soluble and membrane-bound interleukin‑6 receptors involved in the pathogenesis of inflammatory diseases.
Avtozma is a biosimilar medicinal product. It is highly similar to the reference product RoActemra (tocilizumab), which was authorised in the EU on 16 January 2009. Data show that Avtozma has comparable quality, safety and efficacy to RoActemra (tocilizumab).
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