A Comprehensive Review of Evidence and Challenges in Switching from Originator Drugs to Biosimilars of Monoclonal Antibodies: Focus on Rituximab and Trastuzumab
Abstract
Objective: The primary objective of the document is to conduct a comprehensive review of the clinical, economic, and regulatory evidence regarding the transition from originator drugs to biosimilars of monoclonal antibodies, focusing specifically on rituximab and trastuzumab. The review aims to analyze data on biosimilar usage, assess barriers to adoption, explore potential strategies to overcome challenges, with the ultimate goal of improving healthcare sustainability and accessibility.
Data source Study selection: The study selection includes clinical trials, economic analyses, and regulatory reviews focusing on biosimilars of rituximab and trastuzumab. It focuses on phase 3 trials, cost-effectiveness studies, and post-marketing surveillance data for assessing safety, efficacy, and adoption barriers. Real-world evidence and regulatory guidelines from agencies such as EMA and FDA are also considered.
Summary: The article reviews the transition from originator monoclonal antibody drugs to biosimilars, focusing on rituximab and trastuzumab. Topics of clinical evidence, economic benefits, regulatory challenges, and adoption barriers include issues related to immunogenicity concerns and perceived physician-patient acceptance. While offering potentially cost-effective treatments for cancer, further research, harmonization of regulations, and education will allow this value to be realized across more patients, improved outcomes.
Conclusion: The transition from originator drugs to biosimilars, like rituximab and trastuzumab, enhances treatment accessibility and affordability. Clinical evidence supports their safety and efficacy, but challenges remain, including immunogenicity concerns, regulatory differences, and stakeholder perceptions. Addressing these barriers through global harmonization and education can optimize biosimilar adoption and healthcare sustainability.
Keywords: Rituximab, Trastuzumab, Biosimilars, Switching, Monoclonal Antibodies.
Keywords:
Rituximab, Trastuzumab, Biosimilars, Switching, Monoclonal AntibodiesDOI
https://doi.org/10.22270/jddt.v15i2.7012References
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