Risk - Reward of Developing a Herceptin Biosimilar

Report Code: HC-R-17-146 | Page Numbers: 70

Herceptin exclusivity is expiring in major geographies and many Biosimilar players (both experienced and new entrant) are looking to have a share of this potential $6billion pie. Herceptin sales are critical to Roche as it comprise about 15% of its cumulative Pharma sales. While eying for this potential lucrative opportunity, there are several risks and barriers that Biosimilar players should be aware. The report - ?Risk - Reward of Developing a Herceptin biosimilar - A thorough assessment? looks into several aspects of potential opportunity size for Biosimilar players, with regard to:
- European Experience of Biosimilars

- Current market positioning of Herceptin across geography

- Different technologies deployed by biosimilar players

- Competition - Pipeline of Biosimilar and Biobetters targeting Herceptin

- Potential Market Expansion post expiry of Market Exclusivity

- Defense Strategies deployed by Roche

- Ongoing Clinical trials and their impact on Market Opportunity

- Global Regulatory Process and Hurdles

- Risk/Reward profile of developing Herceptin biosimilar

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Herceptin exclusivity is expiring in major geographies and many Biosimilar players (both experienced and new entrant) are looking to have a share of this potential $6billion pie. Herceptin sales are critical to Roche as it comprise about 15% of its cumulative Pharma sales. While eying for this potential lucrative opportunity, there are several risks and barriers that Biosimilar players should be aware. The report - ?Risk - Reward of Developing a Herceptin biosimilar - A thorough assessment? looks into several aspects of potential opportunity size for Biosimilar players, with regard to:
- European Experience of Biosimilars

- Current market positioning of Herceptin across geography

- Different technologies deployed by biosimilar players

- Competition - Pipeline of Biosimilar and Biobetters targeting Herceptin

- Potential Market Expansion post expiry of Market Exclusivity

- Defense Strategies deployed by Roche

- Ongoing Clinical trials and their impact on Market Opportunity

- Global Regulatory Process and Hurdles

- Risk/Reward profile of developing Herceptin biosimilar

Herceptin exclusivity is expiring in major geographies and many Biosimilar players (both experienced and new entrant) are looking to have a share of this potential $6billion pie. Herceptin sales are critical to Roche as it comprise about 15% of its cumulative Pharma sales. While eying for this potential lucrative opportunity, there are several risks and barriers that Biosimilar players should be aware. The report - ?Risk - Reward of Developing a Herceptin biosimilar - A thorough assessment? looks into several aspects of potential opportunity size for Biosimilar players, with regard to:
- European Experience of Biosimilars

- Current market positioning of Herceptin across geography

- Different technologies deployed by biosimilar players

- Competition - Pipeline of Biosimilar and Biobetters targeting Herceptin

- Potential Market Expansion post expiry of Market Exclusivity

- Defense Strategies deployed by Roche

- Ongoing Clinical trials and their impact on Market Opportunity

- Global Regulatory Process and Hurdles

- Risk/Reward profile of developing Herceptin biosimilar

Table of Contents
1. Executive Summary

2. European experience of Biosimilar launch
- Pricing
- Market share dynamics

3. Introduction- Herceptin
- Geography-wise Sales Forecast until patent expiry
- Patent expiries in major geographies
- Pricing in major geographies
- Penetration in major emerging markets
- Expected market expansion post patent expiry
- Ongoing Clinical trials on Herceptin

4. About the biosimilar space
- Different technologies deployed by biosimilar players
- Partnering deals in biosimilar
- Cost of developing biosimilar/biobetter
- Comparison USFDA and EUROPE biosimilar guideline
- Requirement of Analytical methods
- Interchangeability and substitution
- Regulatory review process for biosimilar- Principle and Concepts
- Bridging Studies- A way to reduce the launch timeline in multiple geographies
- Importance of post-marketing safety in Non-ICH countries
- A brief on biosimilar approval guidelines in geographies other than US and Europe

5. Pipeline of Herceptin Biosimilar and Biobetters
- Ongoing Clinical trials on Herceptin biosimilar/biobetter
- A brief on companies developing Herceptin biosimilar
- Financial capability
- Technical capability

6. Opportunities and Threats for Herceptin Biosimilar
- Defense strategy by Roche to woo away biosimilar threat in global markets and Emerging markets
- Major clinical trials on Herceptin- potential impact on its future sales
- Physician's and Payers adaptation for using Biosimilar
- Competitive threats - Upcoming biobetters and novel biologics in HER2+ve Breast cancer and Gastric cancer

7. Our view on Risk/Reward profile of developing Herceptin Biosimilar
Herceptin exclusivity is expiring in major geographies and many Biosimilar players (both experienced and new entrant) are looking to have a share of this potential $6billion pie. Herceptin sales are critical to Roche as it comprise about 15% of its cumulative Pharma sales. While eying for this potential lucrative opportunity, there are several risks and barriers that Biosimilar players should be aware. The report - ?Risk - Reward of Developing a Herceptin biosimilar - A thorough assessment? looks into several aspects of potential opportunity size for Biosimilar players, with regard to:
- European Experience of Biosimilars

- Current market positioning of Herceptin across geography

- Different technologies deployed by biosimilar players

- Competition - Pipeline of Biosimilar and Biobetters targeting Herceptin

- Potential Market Expansion post expiry of Market Exclusivity

- Defense Strategies deployed by Roche

- Ongoing Clinical trials and their impact on Market Opportunity

- Global Regulatory Process and Hurdles

- Risk/Reward profile of developing Herceptin biosimilar

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