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Therapy Class Overview : Rituximab biosimilar Product Image

Therapy Class Overview : Rituximab biosimilar

  • ID: 2686166
  • October 2013
  • 45 Pages
  • MP Advisors

Approval of Inflectra/Remsima, the first biosimilar Monoclonal antibody (Mab) from Celltrion and Hospira in EU in 2013 is a trend setter!

Inflectra is a biosimilar of Johnson & Johnson's Remicade, which is approved for RA, Crohn's disease and several other conditions and had $2 billion in sales in Europe last year. This approval has further increase the optimism of companies developing and marketing biosimilars and the wait for the launch of others in queue Rituxan, Herecptin, Enbrel etc may not be too long. These three drugs alone had worldwide sales of ~$21b in 2012.

Commercial success of biosimilars will be depend both on affordability and accessibility assuming that the “copy molecule” is at par on efficacy, safety and similarity with the branded product. Uptake and marketing strategy of Remicade biosimilar will be closely watched by investors as well as companies developing/marketing Biosimilars. In this report, we have analyzed the market opportunity of rituximab biosimilar.

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 spaceDifferent 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"

List of Tables:

Table 1
Rituxan/MabThera's Biosimilar
BIOLOGICS PATENT EXPIRY TILL 2017

Table 2
Rituxan/MabThera's Biosimilar
BIOSIMILAR PIPELINE

Table 3
Rituxan/MabThera's Biosimilar
PRICE DIFFERENCE BETWEEN REFERENCE PRODUCTS AND BIOSIMILARS

Table 4
Rituxan/MabThera's Biosimilar
RITUXIMAB PATENT EXPIRIES

Table 5
Rituxan/MabThera's Biosimilar
PROJECTED RITUXIMAB SALES TILL 2017

Table 6
Rituxan/MabThera_Biosimilar
COMPETITION FROM KEY MARKETED DRUGS

Table 7
Rituxan/MabThera's Biosimilar
EFFICACY TARGET PROFILE OF GA101 IN CLINICAL STUDIES

Table 8
Rituxan/MabThera's Biosimilar
OBINUTUZUMAB: PHIII CLINICAL STUDY

Table 9
Rituxan/MabThera's Biosimilar
OBINUTUZUMAB: PHI/II CLINICAL STUDY

Table 10A
Rituxan/MabThera's Biosimilar
RITUXIMAB DEVELOPMENT PROGRAMS - IMMUNOLOGY

Table 10B
Rituxan/MabThera's Biosimilar
RITUXIMAB DEVELOPMENT PROGRAMS - ONCOLOGY

Table 11
Rituxan/MabThera's Biosimilar
COMPETITIVE LANDSCAPE – RITUXIMAB

Table 12
Rituxan/MabThera's Biosimilar
SELECT RA DRUGS IN DEVELOPMENT

Table 13
Rituxan/MabThera's Biosimilar
ANALYTICAL ATTRIBUTES FOR CHARACTERIZATION OF BIOSIMILAR

Table 14
Rituxan/MabThera's Biosimilar
FDA APPROVED PRODUCTS USING ANIMAL/YEAST ALTERNATIVE EXPRESSION SYSTEM

Table 15
Rituxan/MabThera's Biosimilar
MABS – EVOLUTION OF TECHNOLOGIES- FROM MOUSE TO HUMAN

- Bio-better
- Biogen Idec
- CLL
- DLBCL
- Dr Reddys
- Enbrel
- GA-101
- Genentech
- MabThera
- NHL
- Obinutuzumab
- Ofatumumab
- RA
- Reditux
- Remicade
- Rituxan
- Roche
- Type II
- anti-CD20
- biologics
- biosimilar
- life cycle management
- monoclonal antibody
- rituximab

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