Rituximab Biosimilar in Therapeutic – Company Overview, Market Opportunities and Threats, Market Share Dynamics

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.

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Table Of Contents

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

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