Cri-report - Risk Reward Of Developing A Herceptin Biosimilar A Thorough Assessment

(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

by: sara

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