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This report examines the extent to which order of market entry influences the prospects of achieving a satisfactory return on investment for companies developing branded generic and generic inhaled products This emphasizes the importance of developers making frank assessments of their ability to reach the market ahead of their competitors

Features and benefits

Analysis and interpretation of EU and US regulation relating to branded generic and generic orally inhaled products

Economic assessment (NPV analysis) of branded generic and generic Advair and Symbicort competitors that will launch in the EU and US

Highlights

Review of the current asthma and chronic obstructive pulmonary disease market and significant historical events that shaped this market

Strategic review of challenges faced by companies bringing branded generic and generic versions of Advair and Symbicort to market

Profit and loss and economic analysis of branded generic and generic inhalation products that will come to market

Your key questions answered

How much does it cost to bring a branded generic or generic inhalation product to the market?

What are the differences in current regulatory guidance in the EU and US for orally inhaled products and how should the guidance be interpreted?

What steps are followed to develop and bring the products to market?

What is the approach being taken by Mylan to bring generic Advair to market?

What return on investment can manufacturers of branded generic or generic inhalation products expect if they come to market?

Table Of Contents

Profitability Assessment of Branded Generic Inhalers
TABLE OF CONTENTS
LIST OF FIGURES
LIST OF TABLES
5 EXECUTIVE SUMMARY
7 INTRODUCTION
8 Bibliography
10 REGULATORY LANDSCAPE REVIEW
10 Regulatory pathway in Europe
17 Regulatory pathway in the US
24 Regulatory pathway summary
25 Bibliography
27 FORECASTING AND ECONOMIC ASSESSMENT
27 Forecasting approach
31 US: Advair forecast
32 EU: Symbicort and Advair forecast
35 Profit and loss analysis
40 Economic appraisal
43 Bibliography
45 CONCLUSION
46 APPENDIX 1
47 APPENDIX 2
48 BIOGRAPHIES

List of Figures

27 Figure 1: Patient flow diagram
28 Figure 2: Potential uptake curves diagram
31 Figure 3: Forecast assumptions for Advair Gx/BGx
33 Figure 4: Forecast assumptions for Symbicort BGx
34 Figure 5: Forecast assumptions for Advair BGx

List of Tables

13 Table 1: Clinical trials conducted to support the approvals of AirFluSal Forspiro, DuoResp
Spiromax, and Bufomix Easyhaler
18 Table 2: FDA guidance for bioequivalent AB-rated Advair generics
21 Table 3: Comparison of development pathway for Mylan MGR001 vs Teva FS Spiromax
22 Table 4: Comparison of development pathway for Teva ProAir Spiromax vs SkyePharma
Flutiform
30 Table 5: Zipf market share distribution
36 Table 6: Clinical trial costs per patient, by phase
36 Table 7: Costs for clinical trials conducted by Teva for DuoResp Spiromax
38 Table 8: Device development: a review of respiratory device transactions
41 Table 9: Advair Gx/BGx US: summary PandL
41 Table 10: Advair BGx EU: summary PandL
42 Table 11: Symbicort BGx EU: summary PandL

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