Recent progress in biosimilars development is overviewed, with attention to the history of issues and processes leading to current regulations, and to scientific considerations, including progress on design and operational implementation issues that arise and are peculiar to biosimilars trial design and implementation.
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[Efficacy and safety of transarterial chemoembolization combined with sintilimab and bevacizumab biosimilar for unresectable hepatocellular carcinoma].
Zhonghua Nei Ke Za Zhi
February 2025
Department of Interventional Radiology, the First Affiliated Hospital of Soochow University, Suzhou215000, China.
To investigate the efficacy and safety of transarterial chemoembolization (TACE) combined with sintilimab and bevacizumab biosimilar in the treatment of unresectable hepatocellular careinoma (uHCC). The clinical data of 64 patients with unresectable HCC, who were admitted to the First Affiliated Hospital of Soochow University between January 2021 and December 2023, were retrospectively analyzed. The patients were divided into a combination group (=43, receiving TACE combined with sintilimab and bevacizumab biosimilar) and control group (=21, receiving only sintilimab and bevacizumab biosimilar).
View Article and Find Full Text PDFEvaluation of the Safety and Efficacy of Trastuzumab Emtansine (T-DM1) Biosimilar in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer: Findings From a Single-Center Retrospective Analysis in India.
Cureus
December 2024
Medical Affairs, Zydus Lifesciences, Ahmedabad, IND.
Background Human epidermal growth factor receptor 2 (HER2)-positive breast cancer is a highly aggressive subtype characterized by a high recurrence rate. Trastuzumab emtansine (T-DM1), an antibody-drug conjugate targeting HER2, has shown improved outcomes; however, its effectiveness in cases with brain metastases remains unclear. The T-DM1 biosimilar has emerged as a cost-effective treatment option.
View Article and Find Full Text PDFComparing PD-L1 and PD-1 inhibitors plus bevacizumab combined with hepatic arterial interventional therapies in unresetable hepatocellular carcinoma: A single-center, real-world study.
Int J Cancer
January 2025
State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University, Guangzhou, PR China.
With the rise of anti-vascular endothelial growth factor antibody and programmed cell death-ligand 1 (PD-L1) regimens, particularly bevacizumab and atezolizumab, as first-line treatments for advanced hepatocellular carcinoma (HCC), there is a need to explore PD-L1 and programmed cell death 1 inhibitors in combination therapies for unresectable HCC (uHCC). Integrating systemic therapies with locoregional approaches is also emerging as a potent strategy. This study compares the outcomes of atezolizumab (PD-L1 inhibitor) and sintilimab (programmed cell death 1 inhibitor) with bevacizumab or its biosimilar, combined with hepatic arterial interventional therapies (HAIT) in uHCC patients.
View Article and Find Full Text PDFCost effectiveness of different treatment strategies with natalizumab for pregnant women with multiple sclerosis.
J Neurol
January 2025
Care Policy and Evaluation Centre, London School of Economics and Political Science, London, WC2A 2AE, UK.
Background: The management of multiple sclerosis (MS) during pregnancy poses significant challenges. This study aimed to evaluate the cost-effectiveness of three natalizumab treatment strategies during pregnancy from the UK healthcare system's perspective.
Methods: A Markov model was developed to assess the health outcomes and costs associated with three treatment strategies: continuous natalizumab treatment throughout pregnancy, treatment until the first trimester followed by discontinuation, and discontinuation at conception with resumption post-pregnancy.
Phase 2 study of serplulimab with the bevacizumab biosimilar HLX04 in the first-line treatment of advanced hepatocellular carcinoma.
Cancer Immunol Immunother
January 2025
Liver Cancer Institute, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Xuhui District, Shanghai, 200032, China.
Introduction: This study aimed to evaluate the safety and preliminary efficacy of serplulimab, a novel programmed death-1 inhibitor, with or without bevacizumab biosimilar HLX04 as first-line treatment in patients with advanced hepatocellular carcinoma.
Methods: This open-label, multicenter phase 2 study (clinicaltrials.gov identifier NCT03973112) was conducted in China and consisted of four treatment groups: group A (serplulimab 3 mg/kg plus HLX04 5 mg/kg, subsequent-line), group B (serplulimab 3 mg/kg plus HLX04 10 mg/kg, subsequent-line), group C (serplulimab 3 mg/kg, subsequent-line) and group D (serplulimab 3 mg/kg plus HLX04 10 mg/kg, first-line).
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