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Biosimilars in Immunology

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  • 137 Pages
  • February 2020
  • Region: Global
  • GlobalData
  • ID: 5008521
Biosimilars in Immunology


"The publisher’s Biosimilars in Immunology Thematic Analysis report combines key opinion leader insight and interviews with payers in the US, France, Germany, Italy, Spain, the UK, Japan, India and South Korea to provide an in-depth review of the biosimilars market for major autoimmune diseases."

The report includes an assessment of ongoing clinical trials, the geographical location of trial sponsors, discussion of the key players in the medical marijuana space as well as insights from industry experts discussing market challenges and considerations of stakeholders in the arena."

Europe leads the way for immunology biosimilars in the 7MM, and India is at the forefront in the emerging markets. In terms of immunology biosimilar penetration, the 5EU and India demonstrate the highest favorability towards uptake of biosimilars.

Japan and South Korea have an intermediate biosimilar penetration index, while the US market is the least favorable towards biosimilars. Pricing is a key issue for expensive-to-develop biosimilars entering an increasingly crowded autoimmune disease market.Biosimilars are intended to relieve healthcare-associated cost burden; however, the economic effects of incorporating them into clinical practice are unclear, due to increased time and staff costs required for switching patients onto biosimilars.

Pricing can be a differentiating strategy among different biosimilars and larger discounts over originator brands can boost greater uptake of specific biosimilars. Quotas dictate prescribing patterns in the 5EU; however, physicians show concern about switching to a biosimilar from the originator brand. The majority of KOLs interviewed by The publisher indicated that they used biosimilars mostly for new patients. KOLs also cited reluctance to switch existing patients to biosimilars, highlighting that they did not want to change a biologic treatment that was working for the patient.

Other reasons against switching included lack of incentives for physicians, lack of switching data, and nocebo effects.Biogen, Sandoz, Pfizer, and Amgen are dominating the immunology biosimilars field. The immunology biosimilars space is dominated in developed markets by established brand names, including Biogen, Sandoz, Pfizer, and Amgen.

In India and South Korea, major biosimilar players include Celltrion, Cipla, and Zydus Cadila.


Components of the report include -
  • Introduction to Biosimilars in Immunology - Defining biosimilars in immunology and discussing the history of drugs approved across the 9MM.
  • Assessment of Marketed and Pipeline Products - An overview of biosimilar products on the market and drugs currently in clinical development.
  • Regulatory Strategies - Overview of biosimilar regulatory strategies by country.
  • Market Dynamics - Overview of biosimilar market dynamics by country.
  • Focus Indications and Market Potential - In-depth assessment of biosimilars in major autoimmune indications, market potential as well as drivers and barriers to uptake.

Reasons to Buy
  • Key Players - In-depth assessment of key players in the space across the 9MM
  • Key Clinical and Commercial Concepts - An examination of key clinical and commercial concepts in the biosimilars in immunology space, based on KOL and payer insights.
  • Pricing and reimbursement infrastructure and challenges are examined.
  • Future Opportunities - Overview of future strategies recommended by KOLs and payers for boosting biosimilar uptake is discussed.

Table of Contents

1. Preface
1.1 Related Reports
1.2 Upcoming Reports
1.3 Abbreviations

2. Executive Summary
2.1 Key Findings
2.2 KOL and Payer Insights

3. Introduction
3.1 What Is a Biosimilar?
3.2 Timeline of Immunology Biosimilar Development
3.3 Marketed and Pipeline Immunology Biosimilars in the 9MM

4. Biosimilar Regulatory Pathways Across Geographies
4.1 Biosimilar Regulatory Pathways
4.2 US Biosimilar Regulatory Pathway
4.3 EU Biosimilar Regulatory Pathway
4.4 Japan Biosimilar Regulatory Pathway
4.5 South Korea Biosimilar Regulatory Pathway
4.6 India Biosimilar Regulatory Pathway

5. Biosimilar Country-Specific Dynamics, 9MM
5.1 Biosimilar Country-Specific Dynamics, 9MM
5.2 US Biosimilar Market Potential
5.3 5EU Biosimilar Market Potential
5.4 Japan Biosimilar Market Potential
5.5 South Korea Biosimilar Market Potential
5.6 India Biosimilar Market Potential

6. Important Indications in Immunology
6.1 Biologic Use in Immunology
6.2 Rheumatoid Arthritis
6.3 Psoriatic Arthritis
6.4 Axial Spondyloarthritis
6.5 Ulcerative Colitis
6.6 Crohn’s Disease
6.7 Plaque Psoriasis

7. Major Players
7.1 Importance of Manufacturer Reputation
7.2 Sandoz
7.3 Celltrion
7.4 Amgen
7.5 Mylan and Biocon
7.6 Pfizer
7.7 Biogen

8. Biosimilars - Key Clinical and Commercial Concepts
8.1 Cost Savings and Market Access
8.2 Patient Type
8.3 Prescription Quotas
8.4 Biosimilarity and Interchangeability
8.5 Brand Preference
8.6 Extrapolation of Data

9. Opportunities for Biosimilar Manufacturers
9.1 Strategies for Increasing Uptake of Biosimilars
9.2 Differentiation by Pricing
9.3 Differentiation by Innovation

10. Appendix
10.1 Primary Research
10.2 Sources
10.3 About the Authors
10.4 About the publisher
10.5 Contact Information
10.6 Disclaimer

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Abbvie
  • Amgen
  • Alexion
  • Johnson & Johnson
  • Novartis
  • Bristol Myers Squib
  • Takeda
  • Sanofi
  • Roche
  • Pfizer
  • UCB
  • Biogen
  • Sandoz
  • Hetero Pharmaceuticals
  • Mylan
  • Biocon
  • Cipla
  • Zydus Cadila
  • Fresenius Kabi
  • Samsung Bioe