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Biosimilars: Patent Cliffs and Regulatory Changes Driving the Growth, Competitive Scenario and Market Dynamics

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  • 110 Pages
  • June 2018
  • Region: Global
  • Ingenious e-Brain Solutions
  • ID: 4599605
Biosimilars are in the limelight with various leaders in the biopharmaceutical industry eyeing these biosimilars, be it biologic innovators, generic manufacturers or contract channel partners.

As per who Guidelines, A biosimilar is a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product.

The emergence of biosimilar medicines across Europe and in the United States brings the promise of new valuable sources. The forecast of more affordable options that are safe and effective opens opportunities for health systems to broaden accessibility to biologics for more patients, make resources available for investment in new domains, and bring down healthcare budgets.

With better defined regulatory pathways and expiries, Biosimilars Market will be boosted and will return a stupendous CAGR of more than 55% over the forecast period.

This report highlights the benefits and opportunities of Biosimilars in the biopharmaceutical industry, in comparison to biologics and bio betters.

The report also mentions the development strategy of Biosimilars, the regulatory framework, and approvals required for development as well as the strategies to globally commercialize biosimilars for healthcare benefits.

The information regarding biosimilars pipeline available as of now along with the upcoming clinical trials of other drugs, expiration status of major biosimilars and the emerging players to look out for is also available in this report.

Market Overview of Biosimilars market has been highlighted w.r.t. to various factors that determine the market, market segmentation by region, product, disease indication, etc.

We offer tailored information as per client needs viz. additional company profiling (up to 10), partner identification, regions which are untapped, key strategies employed by the target companies for their sustenance in the studied field etc.

Table of Contents

1. Executive Summary2. Introduction
3. Biosimilars- Overview
3.1 Understanding the domain of biosimilars
3.2 Potential of biosimilars in medicines
3.3 Biosimilars vs Generics
3.4 Biosimilars vs Bio-betters
3.5 Benefits and Opportunities
4. Commercial & Technical Analysis-Biosimilars
4.1 Developmental Strategy
4.1.1 Research & Development
4.1.2 Commercial Strategies
4.2 Biosimilars- Regulation & Approval
4.2.1 FDA approval in U.S.
4.2.2 European Medicines Agency approval in E.U.
4.2.3 Safety of biosimilars
4.3 Current Competitive Scenario and Trend
4.3.1 expiration status of key biosimilars
4.3.2 Original Drugs & their biosimilars
4.3.3 Global Clinical Pipeline by phases
4.3.4 Global Clinical Pipeline by target indication
4.3.5 Ongoing Clinical trials
4.3.6 Scenario in key geographies
4.3.7 Key players to look out
4.3.8 Recent Merger/Acquisitions and/or Collaborations
4.3.9 Press Releases/Investor Updates of the Companies and Universities
5. Biosimilars: Market Overview
5.1 Biosimilars-Segmentation-By Region
5.1.1 Biosimilars Market Segmentation-North America
5.1.2 Biosimilars Market Segmentation-Europe
5.1.3 Biosimilars Market Segmentation-Asia Pacific
5.2 Biosimilars Market Segmentation-By Disease Indications
5.3 Biosimilars Market segmentation-By Product Type
6. Biosimilars - Market Determinants7. Biosimilars - Opportunity Vs. Restraints8. Biosimilars Strategic Analysis SWOT & PEST9. List of Tables10. List of Figures
11. Appendix
11.1 Definitions
11.2 Acronyms
11.3 Sources
11.4 Research Methodology
11.5 Contact Us
11.6 Disclaimer