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市場調查報告書

生技仿製藥的未來:2016年

The Future of Biosimilars 2016

出版商 FirstWord 商品編碼 301229
出版日期 內容資訊 英文
商品交期: 最快1-2個工作天內
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生技仿製藥的未來:2016年 The Future of Biosimilars 2016
出版日期: 2016年07月01日 內容資訊: 英文
簡介

本報告針對生技仿製藥市場將來形成的各種影響因素進行調查、提供生技仿製藥市場現狀、現在市場課題、臨床開發、基本設施、檔案等投資動向、商業發展狀況、法規與互相兼容性課題、訴訟相關策略、將來主要企業、下個目標藥物分析。

調查目的、調查方法

生技仿製藥市場的現在

  • 主要考察
  • 概要
  • 持續穩定發展的生技仿製藥市場與少許不確定要素
  • 依然存在的法規課題、許多美國互相兼容性問題
  • 對臨床開發的投資持續擴大、許多計畫已達最後檢查階段
    • 生技仿製藥環境:等級分類
    • 生技仿製藥環境:分子分類
  • 國家政策持續進化:有國家直接表示支持生技仿製藥
  • 訴訟:企業的攻防策略
  • 開始商業面的促進生技仿製藥引進的基本設施、計畫、合作投資

現在的生技仿製藥市場課題

  • 主要考察
  • 改善對生技仿製藥的認識、更深一層的加深認知度與理解
  • 法規方面互相兼容性為主要課題
  • 促進生技仿製藥引進的因素與阻礙相關見解

生技仿製藥市場發展

  • 主要考察
  • FDA:是否有足夠的資料確認生技仿製藥可用性?
  • FDA的互相兼容性指南預測
  • 為支援可用同一分子生技仿製藥、要準備什麼等級的臨床資料?
  • 可用同一分子的複數生技仿製藥市場該如何應對?
  • 國家或地區倡議的生技仿製藥引進率影響?
  • 律師是最後的勝利者?
  • 商業化重要促進因素是?
  • 將來目標選擇
  • 哪家企業將代表生技仿製藥市場的第二個十年?

結論

附錄

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目錄
Product Code: 596200500

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

Table of Contents(SAMPLE)

Research objectives and methodology

  • Objectives
  • Methodology

What's been happening in the biosimilars market ?

  • Key insights
  • Overview
  • The biosimilars market continues to make god progress, and the remaining issues are focused on a smaller number of uncertainties
  • Regulatory issues remain, with much of the debate now focused on interchangeability in the US
    • The EMA continues to refine a well-established, and highly respected framework
    • More progress in the US, but no sign of its stance on interchangeability
    • Events elsewhere suggest regulatory standards are rising, but still have some way to go before catching Europe and the US
  • Investment in clinical development activity continues to grow, with many programmes now coming to the end of late-stage testing
    • Biosimilar landscape by class
    • Biosimilar landscape by molecule
  • Noational policy continues to evolve, with several countries now openly supporting biosimilar switching
  • Litigation remains a key offensive and defensive strategy for companies involved in the biosimilars market, but results have been mixed
  • The commercial story is beginning to unfold, with investments in infrastructure, portfolios and partnerships focused on driving biosimilar adoption

What are the key issues being debated in the biosimilars market today ?

  • Key insights
  • Attitudes toward biosimilars are improving, but more needs to be done to improve awareness and understanding
  • From a regulatory perspective, interchangeability is the key open question
  • Views on what drives biosimilar uptake, and what could slow it down, have crystalised in recent months

Where are things headed for the biosimilars market?

  • Key insights
  • Does the FDA have enough resources to review biosimilar applications?
  • What's likely to happen with the FDA's interchangeability guideline?
  • What level of clinical data will be needed to support biosimilars of the same molecule available?
  • How will the markets respond to having multiple biosimilars of the same molecule available?
  • What could be the impact of national and local initiatives on biosimilar adoption rates?
  • Will the lawyers have the last laugh?
  • What are the critical commercialisation levers that need to be pulled?
  • What about future target selection?
  • Which companies will be present at the end of the biosimilars market's second decade?

Concluding remarks

Appendix

  • Biologic sales data
  • Expert biographies
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