EMA's CHMP Recommends Approval of Six New Biosimilars
核心洞察
The European Medicines Agency's CHMP has recommended approving six new biosimilars, expanding treatment options for various conditions.
Celltrion's AVTOZVMA (tocilizumab) biosimilar received a positive opinion for treating rheumatoid arthritis (搜索), COVID-19 (搜索), and other inflammatory conditions.
Biocon's YESTINTEK (ustekinumab) biosimilar was recommended for approval in treating plaque psoriasis (搜索), psoriatic arthritis (搜索), and Crohn's disease (搜索).
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive recommendations for the approval of six new biosimilars, marking a significant step in expanding treatment options for a range of diseases. These recommendations, if approved by the European Commission, will allow for broader access to potentially more affordable treatment alternatives for patients across Europe.
Celltrion's Biosimilars
Celltrion received positive opinions for four biosimilars. AVTOZVMA (tocilizumab) is intended for the treatment of rheumatoid arthritis (搜索), systemic juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, giant cell arteritis (搜索), CAR-T cell-induced severe or life-threatening cytokine release syndrome, and COVID-19 (搜索). EYDENZELT (aflibercept) is aimed at treating neovascular age-related macular degeneration (搜索), visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular edema (搜索), and visual impairment due to myopic choroidal neovascularization. OSENVELT (denosumab) is recommended for preventing bone complications in adults with advanced cancer involving the bone and treating adults and skeletally mature adolescents with giant cell bone tumor. STOBOCLO (denosumab) is for treating osteoporosis (搜索) in postmenopausal women, bone loss linked to hormone ablation in men at increased risk of fractures, and bone loss associated with long-term treatment with systemic glucocorticoid.
Biocon's Ustekinumab Biosimilar
Biocon's YESTINTEK (ustekinumab) received a positive recommendation for treating adults and children with plaque psoriasis (搜索) and adults with psoriatic arthritis (搜索) or Crohn’s disease. Ustekinumab is a human monoclonal antibody that targets interleukin-12 (搜索) and interleukin-23 (搜索), cytokines believed to play a role in inflammatory and immune responses. This biosimilar offers a potentially more cost-effective alternative to the reference product, potentially increasing access for patients with these chronic inflammatory conditions.
CuraTeq Biologic's Filgrastim Biosimilar
CuraTeq Biologic (搜索)'s ZEFYLTI (filgrastim) was recommended for approval for treating neutropenia (搜索) and mobilizing peripheral blood progenitor cells. Filgrastim is a granulocyte colony-stimulating factor (G-CSF) that stimulates the production of neutrophils, a type of white blood cell. This biosimilar can help reduce the risk of infection in patients undergoing chemotherapy or other treatments that suppress the immune system.