The Future of Biosimilars: Mapping Critical Uncertainties and the Impact of Future Events offers timely insight into the critical biosimilar market issues, and how they could shape the continued evolution of the sector. Key insight is provided to questions such as:
The biosimilar market remains filled with opportunity, but only for those companies that can navigate the complex maze of regulations, clinical development requirements, policies, originator company defensive tactics and physician scepticism. The markets immediate future, however, lies in the balance. From pricing and naming issues, to legal challenges and questions about its profitability, The Future of Biosimilars: Mapping Critical Uncertainties and the Impact of Future Events provides analysis and expert insight into where the market is headed.
Critical stakeholder insight
Based on in-depth telephone interviews and a 50 question survey with biosimilar experts from the US, Europe, Canada and Argentina, FirstView's The Future of Biosimilars: Mapping Critical Uncertainties and the Impact of Future Events lays out the current state of play within the biosimilars market and identifies some key inflection points for the future. Widely researched and filled with expert insight, the report offers the quickest and most up-to-date access to recent and future events in the biosimilars market, including battles being waged over policy, regulatory, intellectual property and commercialisation, and how uncertainties could affect market evolution.
A report for the whole industry
The biosimilars market is evolving quickly, making The Future of Biosimilars: Mapping Critical Uncertainties and the Impact of Future Events a must-read reference not only for those working in biosimilars competitive intelligence, brand strategy, business development and licensing, but also brand forecasting, market research and financial analytics.
Key benefits, features and insights
The biosimilars market is evolving and requires constant updates to keep abreast of changes. In this report, the industry – and particularly those in competitive intelligence, brand strategy, business development, licensing, partnering and alliances – will:
Incisive Questions. Expert Answers. Critical Insights.
This report examines key future events in the biosimilars market. It includes data from extensive secondary research plus the most prominent insights gained from in-depth telephone interviews with 12 biosimilar experts, questionnaires completed by 22 industry experts vetted for their biosimilar market knowledge, discussions with commercial, legal and financial experts, and biosimilar conference proceedings.
Lead Research Analyst
Duncan Emerton, PhD, Senior Director, Syndicated Insights & Analysis, FirstWord
FirstView is a new line of FirstWord reports that aim to provide clients with data, expert opinion and insight on critical market shaping issues and changes in the pharma industry's operating environment. With leading market research capabilities and expertise, a 1-million strong online physician community, FirstView's insights and analysis are 'must read' for industry professionals seeking to understand future pharma market dynamics.
FirstView is headed by Dr Duncan Emerton, Senior Director, Syndicated Insights & Analytics, FirstWord. Duncan has over 15 years' experience in the pharmaceutical industry. He started out in the pharmaceutical industry as a Clinical Research Associate, supporting clinical R&D efforts and several pharma and biotech companies. Roles in clinical project management, sales, marketing and scientific support followed. After leaving Pfizer in 2003, Duncan joined Datamonitor Healthcare. There he worked mainly in strategic consulting roles, with his way final role being that of Director and Biosimilars Practice Lead for Datamonitor Healthcare's Consulting business.
Duncan is an acknowledged expert in the field of biosimilars. He is a regular presenter and chair at biosimilar-focused conferences, and has contributed several articles on biosimilars. Duncan's views on biologics lifecycle management and biosimilars were published in Pharmaceutical Lifecycle Management: Making the Most Out of Each and Every Brand. He has also contributed articles on the potential profitability of biosimilars, myth-busting for biosimilars and key dynamics of the EU biosimilars market.
Duncan holds a BSc(Hons) in Medical Biochemistry from the University of Surrey and a PhD in Microbiology from the University of Kent.
Table of Contents
for The Future of Biosimilars: mapping critical uncertainties and the impact of future events [Published by FirstWord Pharma]
2.Research objectives, methodology and definitions
3.Setting the scene
3.1.Policy changes put in place to drive biosimilar usage could be undone by changes to biosimilar naming, particularly in the US
3.2.Regulatory refinement continues globally, with the FDA’s position on interchangeability the most anticipated development of 2014
3.3.Clinical trial initiations in the mAbs pipeline during 2013 and 2014 demonstrate significant appetite for opportunity
3.4.Legal strategies seeking to defend or invalidate intellectual property, and question biosimilarity claims, gather momentum
3.5.Commercial issues become a significant focus during 2013, with debates over clinical, regulatory and quality now seen as less important
4.Current competitive activity
4.1.Overview of key biologic brands
4.2.Key dynamics of the biosimilar and non-comparable biologic (NCB) landscape
4.3.Biosimilar and NCB development programmes by reference molecule
4.4.Biosimilar and NCB development programmes by therapy area
4.5.Biosimilar and NCB development programmes by drug class
4.6.Biosimilar and NCB development programmes by region and market
4.7.Biosimilar and NCB development programmes by company
5.Future evolution of the biosimilars market
5.1.Overview of key market uncertainties
22.214.171.124.Avastin (bevacizumab; Roche)
126.96.36.199.Enbrel (etanercept; Amgen)
188.8.131.52.Herceptin (trastuzumab; Roche)
184.108.40.206.Humira (adalimumab; AbbVie)
220.127.116.11.Rituxan/MabThera (rituximab; Roche)
18.104.22.168.Remicade (infliximab; Merck & Co./Janssen)
5.2.4.Safety issues from real world data studies
6.2.Lifecycle and portfolio management
6.3.Partnerships and collaborations
6.4.Pricing and payer strategies
6.5.Uptake and profitability
7.2.Defending (and attacking!) intellectual property
7.3.Using other legal methods to slow down biosimilar entry
7.3.1.Citizen petitions and other data injunctions
7.3.2.Seeking invalidation of biosimilarity claims
8.Regulatory and policy
8.3.Interchangeability and automatic substitution
8.5.Regulatory evolution and pathway selection
9.Other potential future events
9.2.Clinical trial results at major conferences
11.1.Experts interviewed for this research
11.2.Biosimilar market dynamics survey
11.3.Regulation and policy
11.5.Legal and intellectual property
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This report is published by FirstWord Pharma
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