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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
