Research and Markets - Global Biosimilar Pipeline and Market Prospects 2017-2022: Focus on Basaglar, Inflectra, Benepali, Rituximab, Trastuzumab, Adalimumab and Bevacizumab
DUBLIN, April 20, 2017 /PRNewswire/ --
Research and Markets has announced the addition of the "Global Biosimilar Pipeline and Market Prospects: Addressing Production Complexities Through Risk Management and Quality by Design" report to their offering.
"Global Biosimilar Pipeline and Market Prospects: Overcoming Production Complexities Through Risk Management and Quality by Design" provides an in-depth assessment of the current trends in the global biosimilars market, with a particular focus on manufacturing complexities and the strategies being implemented to overcome them.
Furthermore, it also positions current biosimilar regulatory frameworks and guidelines implemented in the US, Europe, Japan and China, recent updates regarding the key issue of interchangeability, and case studies of successful biosimilar approvals in recent years.
Government support for biosimilars is increasing in key geographical markets, given the cost saving opportunities that these products represent for national healthcare budgets. A biosimilar is a bio-therapeutic that is clinically highly similar to an approved innovative product (reference product) in terms of active ingredients, and has no meaningful differences in efficacy and safety.
The complexities of manufacturing a biological drug also apply to biosimilars. The complex requirements are manifold and have been a significant barrier to the further expansion of the biosimilars market. One of the key challenges biosimilar manufacturers face is the knowledge gap under which these products are developed. This challenge arises from the fact that the innovator product information remains proprietary and must adopt a reverse engineering process. They also need to adopt the latest technology and quality initiatives, such as QbD, DoE and PAT techniques.
Organizations also need to adopt a proactive approach in risk mitigation through risk-management-plans (RMP) and long-term studies and through being cognizant of adverse events and adopting production best practices outlined by industry associations and regulatory agencies.
A number of biologics will go off patent before 2020, which presents a huge opportunity for biosimilar manufacturers. Pricing discounts for these products usually fall by 30-50% compared with the innovator product. The cost advantages will lead to greater access to these drugs, and significantly reduce the cost of healthcare in many countries.
Key Topics Covered:
1. Executive Summary
2. Introduction
2.1 Defining Biosimilars
2.2 Biosimilar Product Categories
2.3 Comparative Analysis: Biosimilars versus Generics
2.4 Biobetters versus Biosimilars
2.5 What Key Factors Are Driving the Need for Biosimilars?
3. Key Drivers of Growth in the Global Biosimilars Market
3.1 Cost Saving Potential
3.2 Biologics Patent Cliff
3.3 Increasing Clinical Evidence of Product Effectiveness
4. Key Barriers to Growth in the Global Biosimilars Market
4.1 Complexity of Expertise
4.2 Legal Issues
4.3 Biosimilar Interchangeability and Automatic Substitution
4.4 Patient Recruitment
4.5 Competition
5. Biosimilar Regulatory Frameworks in Key Geographies
5.1 EU
5.2 US
5.3 Japan
5.4 China
5.5 Case Studies of Successful Biosimilar Approvals in Key Markets
6. Biosimilar Manufacturing Process
6.1 Biologics
6.2 Biosimilars
6.3 GMP for large molecules
6.4 Biosimilars versus Biologics: Typical Development Timelines and Costs
7. Key Production Issues and Challenges
7.1 Molecular Weight and Complexity
7.3 Environmental Factors
7.4 Knowledge Gap
7.5 Immunogenicity
8. Approaches to Addressing Biosimilar Manufacturing Complexity
8.1 QbD
8.1.1 Reducing Biosimilar Development Risk through QbD
8.2 DoE
8.3 PAT
8.4 Safety and Risk Management
8.5 Production Best Practices
8.6 Alternative Expression System
9. Commercial Strategies for Biosimilars Adopted by Big Pharma
9.1 Big Pharma Biosimilar Strategies
9.2 Entry Strategies for Emerging Markets
9.3 Recommendations
10. Global Biosimilar Pipeline Analysis 2017
10.1 Global Biosimilar Pipeline by Stage of Development
10.2 Global Biosimilar Pipeline by Therapy Area
10.3 Global Biosimilar Pipeline by Molecular Target
10.4 Global Biosimilar Pipeline Company Analysis
10.5 Most Active Companies in the Global Biosimilar Pipeline: Volume of Products by Stage of Development
10.6 Most Active Companies in the Global Biosimilar Pipeline: Volume of Product by Therapy Area
10.7 Biosimilar Clinical Trials by Stage of Development: Average Size of Trials
10.8 Biosimilar Clinical Trials by Stage of Development: Average Trial Duration
10.9 Volume of Biosimilar Clinical Trials 2006-2016
10.10 Volume of Biosimilar Clinical Trials by Phase and Therapy Area
11. Global Biosimilar Market 2017-2022
11.1 Basaglar Global Sales Forecast 2015-2022
11.2 Inflectra Global Sales Forecast 2016-2022
11.3 Benepali Global Sales Forecast 2016-2022
11.4 Rituximab Biosimilar Global Sales Forecast 2019-2022
11.5 Trastuzumab Biosimilar Global Sales Forecast 2019-2022
11.6 Adalimumab Biosimilar Global Sales Forecast 2019-2022
11.7 Bevacizumab Biosimilar Global Sales Forecast 2019-2022
12. Future Outlook
13. Conclusion
For more information about this report visit http://www.researchandmarkets.com/research/69tk6g/global_biosimilar
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