Profitability Assessment of Branded Generic Inhalers

  • ID: 3445974
  • Report
  • Region: Global
  • 48 pages
  • Datamonitor Healthcare
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Analysis and Interpretation of EU and US Regulation Relating to Branded Generic and Generic Orally Inhaled Product
This analysis 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. The analysis shows that, in some cases, sufficiently attractive financial gains cannot be expected beyond the first few market entrants, as indicated by the appearance of negative net present values for later entrants. This emphasizes the importance of developers paying close attention to, and making frank assessments of, their ability to reach the market ahead of their competitors.

This report addresses the following questions:

- What are the regulatory requirements for approval of generic inhaled products in Europe and the US?
- What market share can manufacturers of generic inhaled products expect to achieve depending on their order of market entry?
- Which branded inhaled products should generic manufacturers target in order to achieve commercial success
- What factors should generic inhaled product manufacturers assess when deciding on the economic viability of a new product?

An absence of head-to-head trials, along with biosimilar launches, provide payers with leverage to demand favorable pricing for branded products in exchange for formulary access.

This report addresses the following questions:

- What access controls are payers imposing on interleukins in psoriatic arthritis?
- What discounts and market access levers will be required to drive uptake of interleukins and second-generation TNFalpha inhibitors?
- How do US and European payers view the launch of oral small molecules in psoriatic arthritis?
- What impact will biosimilar entry have on pricing and reimbursement of branded biologics?
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1. Executive Summary

2. Introduction
- Bibliography

3. Regulatory Landscape Review
- Regulatory pathway in Europe
- Regulatory pathway in the US
- Regulatory pathway summary
- Bibliography

4. Forecasting and Economic Assessment
- Forecasting approach
- US: Advair forecast
- EU: Symbicort and Advair forecast
- Profit and loss analysis
- Economic appraisal
- Bibliography

5. Conclusion

Appendix 1
Appendix 2

List of Figures:
Figure 1: Patient flow diagram
Figure 2: Potential uptake curves diagram
Figure 3: Forecast assumptions for Advair Gx/BGx
Figure 4: Forecast assumptions for Symbicort BGx
Figure 5: Forecast assumptions for Advair BGx

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