On 25 April 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorization for nine biosimilar medicines. These include one trastuzumab biosimilar and eight denosumab biosimilars.
Trastuzumab biosimilar Dazublys
Dazublys (trastuzumab) has been developed by CuraTeQ Biologics for treatment of metastatic and early breast cancer.
Trastuzumab is a monoclonal antibody that binds to and inactivates the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancers, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat HER2 positive (HER2+) breast cancers. The originator product, Herceptin, is sold by Roche/Genentech [1].
Eight denosumab biosimilars
Denosumab is a humanized monoclonal antibody that is an inhibitor of the receptor activator of nuclear factor kappa-B ligand (RANKL), which works by preventing the development of osteoclasts which are cells that break down bone. It is used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone and giant cell tumour of bone.
The originator products are Amgen’s Prolia and Xgeva (denosumab). Prolia was approved by the European Medicines Agency (EMA) for the treatment of bone resorption and postmenopausal osteoporosis and Xgeva was approved for the treatment of bone fractures and neoplasm metastasis.
Among the recent positive recommendations for denosumab biosimilars by the EMA’s CHMP are:
Mabxience Research’s Denbrayce (denosumab), Zentiva’s Enwylma (denosumab), Biosimilar Collaborations Ireland Limited’s Vevzuo (denosumab) and Gedeon Richter’s Yaxwer (denosumab), reference Xgeva and are treatments for the prevention of skeletal related events in adults with advanced malignancies, treatment of adults and skeletally mature adolescents with giant cell tumour of bone.
Biosimilar Collaborations Ireland Limited’s Denosumab BBL (denosumab), Mabxience Research’s Izamby (denosumab), Gedeon Richter’s Junod (denosumab) and Zentiva’s Zadenvi (denosumab), reference Prolia, and are recommended for the treatment of osteoporosis and bone loss.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 11]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-trastuzumab
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of denosumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 May 11]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-denosumab
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