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Fast Facts: Biosimilars in Hematology and Oncology
Biologics have revolutionized – and are revolutionizing – the treatment of many serious disorders. The evidence acquired from more than 10 years of clinical experience, with more than 50 biosimilar drugs and more than 700 million patient-days' exposure in Europe, shows that approved biosimilars can be used as safely and effectively as originator biologics. Yet concerns persist about biosimilars – particularly in curative cancer treatment, where they are relatively recent therapeutic options. 'Fast Facts: Biosimilars in Hematology and Oncology' provides a concise overview of emerging global practice in this fast-moving area together with practical information on adding biosimilars to a formulary and switching patients. Contents: ‧ Biologics and the need for biosimilars ‧ Why do we need biosimilars? ‧ How is the quality of biosimilar medicines assured? ‧ Legal issues ‧ Switching, interchangeability and extrapolation ‧ Safety and pharmacovigilant ‧ Global issues ‧ Formulary considerations: pharmacy issues ‧ Formulary considerations: supportive care biosimilars ‧ Formulary considerations: therapeutic anti-cancer biosimilars ‧ Communication and awareness
- Cover
- Title Page
- Copyright
- Contents
- Glossary
- Introduction
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1 Biologics and the need for biosimilars
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Costs and economics
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Generic and biosimilar medicines
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Hematology/oncology
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Variability in structure
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2 Why do we need biosimilars?
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An opportunity to reduce costs
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Brand switching and extrapolation of indications
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3 How is the quality of biosimilar medicines assured?
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Approval and regulation
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Outcomes and endpoints in clinical confirmatory trials
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Totality of evidence
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4 Legal issues
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Timing of biosimilar development
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Development in the USA
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Development in Europe
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5 Switching, interchangeability and extrapolation
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Switching and interchangeability
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Extrapolation
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6 Safety and pharmacovigilance
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Immunogenicity
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Pharmacovigilance
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7 Global issues
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Intended-copy biologics in general
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Intended-copy epoetin
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Intended-copy rituximab
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8 Formulary considerations: pharmacy issues
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Initial assessments for pharmacists
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Safety and efficacy
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Product characteristics
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Manufacturers’ processes
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Storage
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Names and tracking
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Ease of administration
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Compatibility with compounding technology
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Brand-switching strategies
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Patient communication
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Economic considerations
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9 Formulary considerations: supportive care biosimilars
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Epoetin alfa
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Filgrastim and pegfilgrastim
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10 Formulary considerations: therapeutic anti-cancer biosimilars
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Rituximab
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Trastuzumab
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Bevacizumab
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11 Communication and awareness
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Education
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Communicating with one voice
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Implementing policies to enhance uptake of biosimilars
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Redesigning pricing and reimbursement policies
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Differentiation by manufacturers
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- Useful resources
- Index
- 出版地 : 德國
- 語言 : 德文
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