Analysis of USFDAs Approval of BiosimilarsCase in Focus: Zarxio (Biosimilar of Amgens Neupogen)
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Table of Content (Draft)Analysis of USFDAs Approval of Biosimilars
1. Executive Summary
2. Overview: Defi nition: Biological Product Defi nition: Biosimilars The Biologics Price Competition and Innovation Act of 2009
(BPCI Act)
Purple Book First Biosimilars Approved in Key Regions
3. Case Study: US Approval of Zarxio (Biosimilar of Amgens Neupogen) Overview:
What is Zarxio What is Zarzio
What is Filgrastim
Approved Indications for Zarxio Clinical Evidence: Zarxio
Why not Generic Will it be Cheaper? Cost Comparison of Various Regimens of Neupogen, Neulasta,
and Zarzio across 14 days (in EUR)
Comparative Costs (in EUR) of Zarzio, Neupogen, and Neulasta Associated with the Estimates of Treatment across Three Tumor Types
4. Biosimilar Applications Pending/Under Review with USFDA
5. Global Biosimilars Market Global Biosimilars Market Overview Impact on Industry Competition Novartis: The First to Market
6. Mergers and Acquisitions: To Enhance Biosimilar Capabilities
7. Measures Taken by Biotech Focused Companies to Protect Competitive Advantage
8. Biosimilars: Expected to Reduce Prices and Thus Enabling Healthcare Savings
9. Ancillary Services (Temperature Controlled Logistics, Lyophilization): Expected to Increase in the Wake of Biosimilars Approval
10. KOL Comments: Analysis of Statements from Various KOLs
REPORT HIGHLIGHTS: Regulations around approval biosimilars in
the US
An overview of global biosimilar market Case study on the US approval of Zarxio
(Biosimilar of Amgens Neupogen)
Measures taken by biotech focused companies to protect competitive advantage
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Analysis of USFDAs Approval of Biosimilars