The European Medicines Agency’s (EMA) Committee for Medicinal Use Products (CHMP) recently recommended approval of six new biosimilars.
The CHMP recommended approval of four biosimilars developed by Celltrion: (1) AVTOZVMA (tocilizumab), for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis, CAR-T cell-induced severe or life-threatening cytokine release syndrome and COVID-19; (2) EYDENZELT (aflibercept), for the treatment of neovascular age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular edema and visual impairment due to myopic choroidal neovascularization; (3) OSENVELT (denosumab), for the prevention of bone complications in adults with advanced cancer involving the bone, and for the treatment of adults and skeletally mature adolescents with giant cell bone tumour; and (4) STOBOCLO (denosumab), for the treatment of osteoporosis in women who have been through menopause, bone loss linked to hormone ablation in men at increased risk of fractures, and bone loss associated with long-term treatment with systemic glucocorticoid.
The CHMP also recommended approval of Biocon’s YESTINTEK (ustekinumab) for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn’s disease.
Finally, the CHMP also recommended approval of CuraTeq Biologic’s ZEFYLTI (filgrastim), for the treatment of neutropenia and the mobilization of peripheral blood progenitor cells.