Seminars in oncology
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Seminars in oncology · Apr 2014
ReviewBiosimilars in oncology: from development to clinical practice.
Biologics play an integral role in the treatment of cancer not only for their therapeutic effects and ability to improve outcomes, but also as supportive care agents. Biologics are more complex to manufacture and take longer to bring to market. Because biologics are considerably more costly than small-molecule drugs, their use has placed an increasing economic demand on healthcare systems worldwide. ⋯ Clinicians will likely seek out practice guidelines and position statements from established scientific societies to help evaluate key information regarding biosimilars, such as efficacy, safety, comparability, and interchangeability with the reference biologic. Automatic substitution, nomenclature, extrapolation of clinical data from one indication to another, as well as parameters for ongoing pharmacovigilance are evolving considerations. Education of physicians and other healthcare providers, payers, and patients about biosimilars may facilitate informed decision making, promote acceptance of biosimilars into clinical practice, increase accessibility, and expedite associated health and economic benefits.
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Seminars in oncology · Apr 2014
ReviewPharmacoeconomics of cancer therapies: considerations with the introduction of biosimilars.
Biologics are important treatments for a number of cancers, but they are also significant drivers of globally escalating healthcare costs. Biosimilars have the potential to offer cost-savings with comparable efficacy and safety to innovator products. They are being used in the European Union, Canada, Japan, and Australia and may help with improving health outcomes while minimizing costs to patients and global healthcare systems. ⋯ Optimizing economic efficiency is one part of an ongoing healthcare decision-making process with all therapeutics that aims to attain high levels of quality-of-care and safety given available resources. Some analytic tools stakeholders use to determine the pharmacoeconomic value of a therapy that are highlighted in this review article are opportunity cost, cost-effectiveness, and cost-minimization analyses. These methodologies can provide information to physicians, patients, and payers that may help reaffirm the value of a given biosimilar compared with its reference product throughout its life cycle.