Risk – Reward of Developing a Herceptin Biosimilar – A Thorough Assessment
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
1. EXECUTIVE SUMMARY
2. EUROPEAN EXPERIENCE OF BIOSIMILAR LAUNCH
Pricing
Market share dynamics
3. INTRODUCTIONHERCEPTIN
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 biosimilarPrinciple and Concepts
Bridging StudiesA 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 Herceptinpotential 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
2. EUROPEAN EXPERIENCE OF BIOSIMILAR LAUNCH
Pricing
Market share dynamics
3. INTRODUCTIONHERCEPTIN
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 biosimilarPrinciple and Concepts
Bridging StudiesA 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 Herceptinpotential 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
