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Fast Facts: Biosimilars in Hematology and Oncology

出版社
出版日期
2020/01/24
閱讀格式
EPUB
書籍分類
學科分類
ISBN
9781912776221

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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
  • 1 Biologics and the need for biosimilars
    • Costs and economics
    • Generic and biosimilar medicines
    • Hematology/oncology
    • Variability in structure
  • 2 Why do we need biosimilars?
    • An opportunity to reduce costs
    • Brand switching and extrapolation of indications
  • 3 How is the quality of biosimilar medicines assured?
    • Approval and regulation
    • Outcomes and endpoints in clinical confirmatory trials
    • Totality of evidence
  • 4 Legal issues
    • Timing of biosimilar development
    • Development in the USA
    • Development in Europe
  • 5 Switching, interchangeability and extrapolation
    • Switching and interchangeability
    • Extrapolation
  • 6 Safety and pharmacovigilance
    • Immunogenicity
    • Pharmacovigilance
  • 7 Global issues
    • Intended-copy biologics in general
    • Intended-copy epoetin
    • Intended-copy rituximab
  • 8 Formulary considerations: pharmacy issues
    • Initial assessments for pharmacists
    • Safety and efficacy
    • Product characteristics
    • Manufacturers’ processes
    • Storage
    • Names and tracking
    • Ease of administration
    • Compatibility with compounding technology
    • Brand-switching strategies
    • Patient communication
    • Economic considerations
  • 9 Formulary considerations: supportive care biosimilars
    • Epoetin alfa
    • Filgrastim and pegfilgrastim
  • 10 Formulary considerations: therapeutic anti-cancer biosimilars
    • Rituximab
    • Trastuzumab
    • Bevacizumab
  • 11 Communication and awareness
    • Education
    • Communicating with one voice
    • Implementing policies to enhance uptake of biosimilars
    • Redesigning pricing and reimbursement policies
    • Differentiation by manufacturers
  • Useful resources
  • Index
  • 出版地 德國
  • 語言 德文

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