Fast Facts: Biosimilars in Hematology and Oncology: Biologics and biosimilars - getting decisions right

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