US Biosimilars Market Opportunity & Clinical Pipeline Analysis Report

“US Biosimilars Market Opportunity & Clinical Pipeline Analysis” Report Highlight:

* US Biosimilars Market Introduction
* US Biosimilars Regulatory Scenario
* Unique Features of US Biosimilars Market
* Impact of Biosimilars in US Market
* Impact of Reimbursement Policies on US Biosimilars Market
* Zarxio: First Approved Biosimilar in US
* US Biosimilar Clinical Pipeline By Company, Indication & Phase
* US Biosimilar Clinical Pipeline: 104 Biosimilars
* Marketed Biosimilars: 1 Biosimilar

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Table of Contents

1. US Biosimilars Market Introduction



2. US Biosimilars Regulatory Scenario



3. Unique Features of US Biosimilars Market



4. Impact of Biosimilars in US Market



5. New Biosimilar Categories with High Commercialization Potential

5.1 High Cost-Effectiveness

5.2 Competition

5.3 Nature of Indication

5.4 Nature of Biosimilars

5.5 Cost-Effective Production

5.6 Readily Availability of Biosimilars



6. Impact of Reimbursement Policies on US Biosimilars Market



7. Biobetters: Middle Ground between Biosimilars & Biologics



8. US Biosimilars Market Overview

8.1 Current Market Scenario

8.2 US Biosimilar Clincal Pipeline Overview



9. Zarxio: First Approved Biosimilar in US



10. US Biosimilars Market Dynamics

10.1 Research & Development

10.2 Increasing Demand for Biosimilars

10.3 Increasing Numbers Off-Patent Biologics

10.4 Lesser Competition

10.5 Strong Clinical Pipeline

10.6 Large Number of Indications to be Introduced



11. US Biosimilars Commercialization Challenges



12. US Biosimilars Future Prospects



13. US Biosimilars Market Guidelines

13.1 Scientific Considerations in Demonstration Biosimilarity to a Reference Product

13.2 Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein

Product to a Reference Product

13.3 Nonproprietary Naming of Biological Products

13.4 Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a

Reference Product



14. US Biosimilar Clinical Pipeline By Company, Indication & Phase

14.1 Research

14.2 Preclinical

14.3 Phase-I

14.4 Phase-I/II

14.5 Phase-II

14.6 Phase-III

14.7 Preregistration

14.8 Registered



15. Suspended & Discontued Biosimialrs in Clinical Pipeline

15.1 No Development Reported

15.2 Discountinued

15.3 Preregistration Submission Withdrawal



16. Competitive Landscape

16.1 Amgen

16.2 Apotex

16.3 Boehringer Ingelheim

16.4 Celltrion

16.5 Coherus BioSciences

16.6 Eli Lilly

16.7 EPIRUS Biopharmaceuticals

16.8 Finox Biotech

16.9 Harvest Moon Pharmaceuticals

16.10 Hospira

16.11 Intas Biopharmaceuticals

16.12 Juno Therepeutics (Opus Bio)

16.13 Merck

16.14 Momenta Pharmaceuticals

16.15 Mylan

16.16 Nora Therapeutics

16.17 Novartis

16.18 Oncobiologics

16.19 Pfenex

16.20 Pfizer

16.21 Sandoz

16.22 Wockhardt

Figure 1-1: Benefits of Biosimilar Introduction in US

Figure 1-2: Present Limitations of Biosimilars in US

Figure 1-3: FDA’s Requirements for Biosimilar Products

Figure 2-1: Criterias for Similarity Formulated by Food and Drug Administration (FDA)

Figure 4-1: Global Sales of Neupogen/Neulasta (USD Million), 2012-2014

Figure 4-2: Global Sales of Epogen (USD Million), 2012-2014

Figure 4-3: Global Sales of Neulasta (USD Million), 2012-2014

Figure 4-4: Shares of Amgen Products Exposed to Biosimilars Competition (USD Million), 2014

Figure 5-1: Factors Responsible for Significant Revenue Generation

Figure 7-1: Properties of Biobetters

Figure 7-2: Few Advantages of Biobetters

Figure 7-3: Disadvantages of Biobetters

Figure 8-1: US- Estimated Humira Sales (USD Million), 2012-2014

Figure 8-2: Global Remicade Sales (USD Million), 2012-2014

Figure 8-3: US- MabThera/Rituxan Quarterly Constant Exchange Rate Sales Growth (USD Million), Q3 2014-Q3 2015

Figure 8-4: US-Herceptin Quarterly Constant Exchange Rate Sales Growth (USD Million), Q3 2014- Q3 2015

Figure 8-5: Global Herceptin Quarterly Constant Exchange Rate Sales Growth (USD Million), Q3 2014-Q3 2015

Figure 8-6: Estimated Global Aranesp Sales (USD Million), 2012-2014

Figure 8-7: US- Estimated Aranesp Sales (USD Million), 2012-2017

Figure 8-8: Estimated Sales of Selected Biologics Exposed to Biosimilars Competition, 2014 (USD Million)

Figure 8-9: Estimated Shares of Selected Biologics Exposed to Biosimilars Competition (USD Million), 2014

Figure 8-10: Rank of US among Different Diabetes Prone Countries

Figure 8-11: US Biosimilar Pipeline by Phase (%),2016

Figure 8-12: US Biosimilar Pipeline by Phase (Number),2016

Figure 8-13: No Development Reported US Biosimilar All Pipeline by Phase (%),2016

Figure 8-14: No Development Reported US Biosimilar All Pipeline by Phase (Number),2016

Figure 8-15: Discontinued US Biosimilar All Pipeline by Phase (%),2016

Figure 8-16: Discontinued US Biosimilar All Pipeline by Phase (Numbers),2016

Figure 16-1: Amgen Clinical Pipeline

Figure 16-2: Coherus Bioscience Clinical Pipeline

Figure 16-3: EPIRUS Biopharmaceuticals- Clinical Pipeline

Figure 16-4: Merck Clinical Pipeline

Figure 16-5: Novartis Clinical Pipeline

Figure 16-6: Oncobiologics-Clinical Pipeline

Figure 16-7: Pfenex Clinical Piepline

Figure 16-8: Sandoz Clinical Pipeline



List of Tables



Table 2-1: Major Regulatory Differences Related to Biosimilars in US & EU

Table 2-2: Differences between Biosimilars Applications & Biologics License Applications

Table 4-1: Comparison of Neupogen vs. Zarxio Cost

Table 4-2: Competition to Neupogen

Table 4-3: Amgen’s Biosimilar Competitors in US

Table 4-4: Categories with Potential to Generate Significant Revenues in US Market

Table 5-1: Biosimilars under Food and Drug Administration (FDA) Review

Table 6-1: Categories of Medicare Plan

Table 6-2: Estimated Reimbursement of Zarxio according to Medicare B

Table 7-1: Few Examples of Biologics, Biosimilars and Biobetters

Table 8-1: Biosimilars with High Commercialization Potential in US, 2013-2024

Table 8-2: Companies Involved in Marketing of Rituximab

Table 8-3: Categories with High Potential for Biosimilar Revenue Generation

Table 16-1: Celltrion Clinical Pipeline

Kuick Research is a market research and analytics company that provides targeted information for critical decisions at business, product and service levels. We are quick, predictive and known by the recommendations we have made in the past. Our result-oriented research methodology offers understanding of multiple issues in a short period of time and gives us the capability to keep you full with loads of practical ideas. By translating research answers into strategic insight and direction, we not only rate the success potential of your products and/or services, but also help you identify the opportunities for growth in new demographies and find ways to beat competition.

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