United States Biosimilars Market Opportunity & Clinical Pipeline Analysis 2016 Featuring Zarxio - First Approved Biosimilar in US

Dublin, Feb. 08, 2016 -- Research and Markets (http://www.researchandmarkets.com/research/bq2xpk/us_biosimilars) has announced the addition of the "US Biosimilars Market Opportunity & Clinical Pipeline Analysis" report to their offering.

Biosimilars in US has been approved after a long-time while they have been introduced in other places over a decade ago. Late entry in US market has prevented the patients from getting benefit of biosimilars. Also, spending on healthcare could have been mitigated but absence of proper regulatory framework prevented commercialization of biosimilars in US. Number of indication under biosimilar coverage are also less, single at present, which is going to have modest effect on US market. Number of indications will increase in coming years till then US biosimilar market is expected to grow at modest rates. Slow market growth is of great concern as it is also related to cost cutting by regulators in health care spending. US biosimilars market is at nascent stage and it would take few years to become suitable niche for biosimilars.

Biologics have dominated the US market for several decades due to absence of worthy competitor in different disease segment. In coming years, this situation is expected to change as biosimilars are expected to be commercialized. Zarxio, first US biosimilar, has created lot of enthusiasm among masses but some physicians, investigators and payers have reservation against biosimilars. This scenario may cause hindrance in uptake of biosimilars in coming years. To increase acceptance rates, biosimilar developers have to produce head-to-data confirming pharmacological efficacy. Biosimilars are also expected to have higher cost-effectiveness promoting patients to switch from biologics. In this way, biosimilar developers would be able to generate more revenues by developing positive attitude towards biosimilars.

Newly developed biosimilars in US market are expected to face hard time as regulations are not in place. Both patient and payers are expected to suffer from this issue that has to be resolved as soon as possible. Implication of new rules is expected to take some time as lots of issues have to be solved. Naming of biosimilars and assigning of appropriate billing code is one of the fore most necessities. This situation is likely to deteriorate when monoclonal antibodies will be introduced in US market. Substitution and reimbursement will become easy if clear demarcation is made between which molecule belongs to which category. Regulators are likely to resolve these issues in coming years as they have just entered in biosimilars segment.

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

Key Topics Covered:

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

For more information visit http://www.researchandmarkets.com/research/bq2xpk/us_biosimilars

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