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(CRi-report) -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 Full report: http://www.cri-report.com/biotechnology/5489-risk-reward-of- developing-a-herceptin-biosimilar-a-thorough-assessment.html 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 Full report: http://www.cri-report.com/biotechnology/5489-risk-reward-of- developing-a-herceptin-biosimilar-a-thorough-assessment.html
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Herceptin biosimilar, Roche, thorough assessment, pharma sales, lucrative opportunity, biosimilar players, competitive threats, market research,
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