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The Future of Biosimilars 2016

  • July 2016
  • -
  • Firstword Pharma

Development activity is surging as the focus shifts to commercialisation. How will the market evolve?
The race to commercialise biosimilars is on. What will it take to create a thriving market? Will payers see real cost savings? Will developers make money? What will drive uptake—and what will slow it down?
This must-read report explores how these issues are likely to play out, with first-hand insight from patient groups, physicians, lawyers, and stakeholders from originator and biosimilar companies.
You’ll learn about developers’ market access strategies, originators’ efforts to keep them at bay, key drivers for adoption, and the impact of unresolved regulatory and policy questions. Development is surging, attitudes are improving, and key decisions are imminent. Find out where the market is headed.
“…biosimilars are perfectly poised to come in as part of the solution to the issue of increased pharmaceutical spending.”
- Christine Simmon – SVP & Executive Director, Biosimilars Council, GPhA

“…there's no one size fits all. You really have to look at the market by channel, by therapy area, by country, and then make the right call about how to commercialise your product depending on those factors.”
- Carol Lynch – Global Head of Biopharmaceuticals, Sandoz

Understand the Forces Shaping the Biosimilars Market

Commercialisation: Differentiation may be the key success factor for biosimilars. Discover the strategies manufacturers are using to gain an edge over branded drugs and rival biosimilars.
Regulation: As commercial concerns take centre stage, two important regulatory questions remain unanswered. Find out what they are, and how they’ll affect market access.
Litigation: A defining characteristic of the US market, litigation is now on the rise in Europe too. Learn which actions—defensive and offensive—will have the greatest impact.
Adoption: A decade of experience with biosimilars in Europe has revealed the biggest drivers of adoption. Find out what they are, and what countervailing forces may be slowing down uptake.
Plus, a full market analysis: The number of biosimilars programmes has grown by nearly 15% since last year. Get a breakdown of the current landscape by class and by molecule

Answering Key Questions

Critical mass: A huge number of biosimilars will be ready for regulatory review in the next 12-18 months. Can regulators keep up? What will it mean for the market if they can’t?
No word on interchangeability in the US: What are developers doing to prepare for the (hopefully) imminent release of FDA guidelines? Just how important is an interchangeability designation?
The role of data: How are clinical data requirements for biosimilar applications likely to change? Will analytical data play a bigger role?
Who will switch? How has a decade of experience with biosimilars in Europe shaped attitudes toward switching both treatment-naïve and established patients to biosimilars?
Getting crowded: How will the market handle multiple biosimilars of the same reference drugs? What factors will influence key access and reimbursement decisions?
Emerging opportunities: How do regulatory standards in developing economies compare to those in developed ones? How will they affect future opportunities for developers?
Looking ahead: Events in the next 12-18 months could define the decade to come. How will the market evolve? Who will the key players be, and which reference drugs will they target next?

Expert Contributors
FirstWord interviewed 12 physicians, legal professionals, industry stakeholders, and patient representatives for this report. All interviewees either have direct experience in the development or commercialisation of biosimilars or are considered experts in their respective fields.

Dominic Adair. Partner, Bristows LLP, London, UK
Paul Calvo. Director, Biotechnology/Chemical Group, Sterne, Kessler, Goldstein and Fox, Washington, DC, US
Paul Cornes. UK-based Oncologist
Clare Jacklin. Director of External Affairs, National Rheumatoid Arthritis Society (NRAS), UK
James Kent. Clinical Lead Pharmacist, Southend University Hospital NHS Trust, Westcliff-on-Sea, UK
Patrick Lucy. Founder and Chief Business Officer, Pfenex Inc., San Diego, California, US
Carol Lynch. Global Head of Biopharmaceuticals, Sandoz
Steinar Madsen. Medical Director, the Norwegian Medicines Agency
Christine Simmon. Senior Vice President of Policy & Strategic Alliances, Generic Pharmaceutical Association (GPhA), Washington, DC, US
Martyn G. Smith. Senior member of the Global Biologics Strategy team, F. Hoffmann-La Roche, Switzerland
Florian Strohmaier. Director of Regulatory Affairs & Quality Management, Formycon AG
Anonymous US biosimilars expert. Working for a US-based biotechnology firm

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Table Of Contents

The Future of Biosimilars 2016
1 Executive summary
2 Research objectives and methodology
2.1 Objectives
2.2 Methodology
3 What's been happening in the biosimilars market?
3.1 Key insights
3.2 Overview
3.3 The biosimilars market continues to make good progress, and the remaining issues are focused on a smaller number of uncertainties
3.4 Regulatory issues remain, with much of the debate now focused on interchangeability in the US
3.4.1 The EMA continues to refine a well-established, and highly respected framework
3.4.2 More progress in the US, but no sign of its stance on interchangeability
3.4.3 Events elsewhere suggest regulatory standards are rising, but still have some way to go before catching Europe and the US
3.5 Investment in clinical development activity continues to grow, with many programmes now coming to the end of late-stage testing
3.5.1 Biosimilar landscape by class
3.5.2 Biosimilar landscape by molecule
3.6 National policy continues to evolve, with several countries now openly supporting biosimilar switching
3.7 Litigation remains a key offensive and defensive strategy for companies involved in the biosimilars market, but results have been mixed
3.8 The commercial story is beginning to unfold, with investments in infrastructure, portfolios and partnerships focused on driving biosimilar adoption
4 What are the key issues being debated in the biosimilars market today?
4.1 Key insights
4.2 Attitudes toward biosimilars are improving, but more needs to be done to improve awareness and understanding
4.3 From a regulatory perspective, interchangeability is the key open question
4.4 Views on what drives biosimilar uptake, and what could slow it down, have crystalised in recent months
5 Where are things headed for the biosimilars market?
5.1 Key insights
5.2 Does the FDA have enough resources to review biosimilar applications?
5.3 What's likely to happen with the FDA's interchangeability guideline?
5.4 What level of clinical data will be needed to support biosimilar applications in the future?
5.5 How will the markets respond to having multiple biosimilars of the same molecule available?
5.6 What could be the impact of national and local initiatives on biosimilar adoption rates?
5.7 Will the lawyers have the last laugh?
5.8 What are the critical commercialisation levers that need to be pulled?
5.9 What about future target selection?
5.10 Which companies will be present at the end of the biosimilars market's second decade?
5.11 Is there a sense of optimism about the future of the biosimilars market?
6 Concluding remarks
7 Appendix
7.1 Biologic sales data
7.2 Expert biographies

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