Therapeutic Class Report Overview - Rituxan Biosimilar
The growth in the biosimilar opportunity will be driven by several patent expiries of mega-blockbuster biologics in the next 5 years. Between 2012 and 2017, over $60b worth of sales of biologics in the US/EU will lose patent protection. Out of them, Roche’s/Biogen Idec’s Rituxan/MabThera (rituximab), Merck and JNJ’s Remicade (infliximab), and Amgen and Pfizer’s Enbrel (etanercept) had WW sales of ~$23b in 2011 and have patents expiring in EU and ROW in 2013/14. Biosimilar version of Rituxan was launched by Dr Reddy’s Lab. (DRL), Reditux, in India in 2007 and many others are in the pipeline targeting EU, ROW market; Roche is deploying life-cycle management strategies to protect its Rituximab franchise, which despite competition continues to have a healthy growth rate.
In this report, we have analyzed the market opportunity of Rituximab Biosimilar and its competitive landscape. We believe that despite several clinical setbacks in the Rituxan biosimilars’ pipeline, they could pose a challenge to Rituximab by 2018.
In this report, we have analyzed the market opportunity of Rituximab Biosimilar and its competitive landscape. We believe that despite several clinical setbacks in the Rituxan biosimilars’ pipeline, they could pose a challenge to Rituximab by 2018.
1. EXECUTIVE SUMMARY
First Rituximab Biosimilar -Emerging Market Experience
2. EX-US EXPERIENCE OF BIOSIMILAR LAUNCH
Market Share Dynamics
Pricing –The key to gaining market share?
3. INTRODUCTION - RITUXAN/ MABTHERA (RITUXIMAB)
Patent Expiries in Major Geographies
Geography-wise Sales Forecast Until Patent Expiry
Pricing in Major Geographies
Penetration in Major Emerging Markets
Expected Market Expansion Post Patent Expiry- Dependent on Pricing
4. OPPORTUNITIES AND THREATS FOR RITUXIMAB BIOSIMILAR
Innovator’s Strategy - Roche vs. Biosimilar Players in Global Markets and Emerging Markets
Major Clinical Trials on Rituximab - Potential Impact on its Future Sales
Physician’s and Payers Adaptation for using Biosimilar mAbs
Competitive Threats - Upcoming Bio-betters
Analytical Methods for Rituximab Biosimilar
5. A BRIEF ON COMPANIES DEVELOPING RITUXIMAB BIOSIMILAR –
Dr. Reddy’s
Probiomed
Boehringer Ingelheim
Sandoz
Celltrion
Samsung biologics
Teva/ Lonza
Pfizer
Merck
6. OUR VIEW ON RISK/REWARD PROFILE OF DEVELOPING RITUXIMAB BIOSIMILAR
7. ABOUT THE BIOSIMILAR SPACE
Different Technologies Deployed By Biosimilar Players
Biosimilar mAbs – Evolution of Technologies- From Mouse to Human
New Technology Platforms
Partnering Deals in Biosimilar
Cost Of Developing Biosimilar/Bio-Better
Comparison US FDA 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 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
First Rituximab Biosimilar -Emerging Market Experience
2. EX-US EXPERIENCE OF BIOSIMILAR LAUNCH
Market Share Dynamics
Pricing –The key to gaining market share?
3. INTRODUCTION - RITUXAN/ MABTHERA (RITUXIMAB)
Patent Expiries in Major Geographies
Geography-wise Sales Forecast Until Patent Expiry
Pricing in Major Geographies
Penetration in Major Emerging Markets
Expected Market Expansion Post Patent Expiry- Dependent on Pricing
4. OPPORTUNITIES AND THREATS FOR RITUXIMAB BIOSIMILAR
Innovator’s Strategy - Roche vs. Biosimilar Players in Global Markets and Emerging Markets
Major Clinical Trials on Rituximab - Potential Impact on its Future Sales
Physician’s and Payers Adaptation for using Biosimilar mAbs
Competitive Threats - Upcoming Bio-betters
Analytical Methods for Rituximab Biosimilar
5. A BRIEF ON COMPANIES DEVELOPING RITUXIMAB BIOSIMILAR –
Dr. Reddy’s
Probiomed
Boehringer Ingelheim
Sandoz
Celltrion
Samsung biologics
Teva/ Lonza
Pfizer
Merck
6. OUR VIEW ON RISK/REWARD PROFILE OF DEVELOPING RITUXIMAB BIOSIMILAR
7. ABOUT THE BIOSIMILAR SPACE
Different Technologies Deployed By Biosimilar Players
Biosimilar mAbs – Evolution of Technologies- From Mouse to Human
New Technology Platforms
Partnering Deals in Biosimilar
Cost Of Developing Biosimilar/Bio-Better
Comparison US FDA 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 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
