Oncology

The researchers concluded that the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of PF-05280586 and the reference were similar at the conclusion of the study at week 26.
 
Earlier this week, Daiichi Sankyo announced that it has launched its biosimilar trastuzumab, trastuzumab BS, referencing Herceptin, in Japan. 
The FDA has approved Celltrion and Teva’s rituximab biosimilar, Truxima (rituximab-abbs).
Sandoz announced today that the European Commission has granted a marketing authorization for its pegfilgrastim biosimilar, Ziextenzo, referencing Neulasta. 
 
The European Commission has granted a marketing authorization to Cinfa Biotech and Mundipharma’s biosimilar pegfilgrastim, Pelmeg, for all indications of the reference product, Neulasta.
 
Bevacizumab, an anti–vascular endothelial growth factor treatment for which 1 biosimilar has been approved to date, has been shown to improve quality of life for patients with glioblastoma—and to delay disease progression—but has not prolonged patients’ overall survival. However, recent research suggests that using 4 older drugs together with bevacizumab could provide a more effective treatment protocol.
Some studies have found that granulocyte colony-stimulating factor (G-CSF) therapies are underused for the prophylaxis of febrile neutropenia (FN) in Europe, but the widespread availability of cheaper biosimilar options has led to increased use. A new study, published in BMC Cancer, sought to examine the use of the biosimilar filgrastim, Zarzio, in relationship to European Organisation for Research and Treatment of Cancer (EORTC) guidelines.
The researchers say that their data were consistent with the pharmacokinetic equivalence previously demonstrated in a single-dose PK study that included 202 healthy adult men in the United States and European Union, and thus add to the evidence of ABP-215 as a high-quality biosimilar to bevacizumab for use in Japan. 
Among long-term responders, first-line bevacizumab-based therapy is more effective in patients with HER2-negative metastatic breast cancer (MBC) who were not previously treated with taxanes, a recent Spanish study suggests.
During this week’s International Society for Pharmacoeconomics and Outcomes Research 2018 European meeting, the role of biosimilars in oncology is the subject of several research presentations, all of which underscore the importance of these agents in increasing patient access and driving down costs.
 

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