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  4. > Therapeutic Class Report Overview - Rituxan Biosimilar

Therapeutic Class Report Overview - Rituxan Biosimilar

  • February 2013
  • -
  • MP Advisors
  • -
  • 45 pages

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.

Table Of Contents

Therapeutic Class Report Overview - Rituxan Biosimilar
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

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