Cover Image
市場調查報告書

生技仿製藥相關規範最新趨勢

Biosimilars: Regulatory Outlook

出版商 FirstWord 商品編碼 232502
出版日期 內容資訊 英文
商品交期: 最快1-2個工作天內
價格
Back to Top
生技仿製藥相關規範最新趨勢 Biosimilars: Regulatory Outlook
出版日期: 2015年11月01日 內容資訊: 英文
簡介

本報告針對世界生技仿製藥相關法律規範環境調查、提供支援適應症外推、互換性、命名規則、用語、核准等臨床資料數量與種類等相關法規動向、產業與企業策略影響。

主要課題的回答

  • 核準時間序列表
    • EMA (European Medicines Agency)與FDA (Food and Drug Administration)的比較
  • 分析 vs 臨床
    • FDA、EMA趨勢與世界生技仿製藥法規範影響
  • 命名規則:FDA、EMA、WHO不同的提案
    • 各種優點與市場動力學的影響
  • 互換性
    • 證實生技仿製藥互換性的必要條件
    • 證明後的責任是什麼
    • 是否具有商業優勢
    • 與未來成本降低的關聯性
  • 適應症外推
    • 持續辯論的問題:今後會達成共識嗎
  • 新興市場
    • 有更多患者讓部分新興市場「無法比較的生物製劑 (NCB:Non-comparable biologics)」市場產生盛況
    • 市場今後也將關注患者的動向
    • 西洋法規與道德標準是否相同

檢討課題

  • 生技仿製藥應該在無臨床實驗資料下核准嗎?當局慣性的要求臨床資料嗎?
  • 無法比較的生物製劑 (NCB:Non-comparable biologics) 受到部份新興市場歡迎、配合患者需求、但未來市場包括EU與美國都將朝更嚴格基準前進、是否該以患者為最優先?
  • 當局核准的生技仿製藥是否也受業界支持?還能夠做些什麼?
  • 生技仿製藥核准目前是容易還是困難?會因產品等級與種類不同嗎?
  • 世界法規技術的主要差別?法規、臨床策略的影響?

本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

目錄
Product Code: 596200365

Biosimilars offer a chance to improve access to, and reduce spending on, life-saving biologic therapies. But could regulators do more to support the market? While experts believe significant regulatory progress has been made in recent years, clarity is distinctly lacking on certain issues, such as interchangeability and naming.

FirstWord's Biosimilars: Regulatory Outlook provides insight and opinion on why. This 64 page report gives in-depth and candid views on what eight industry and biosimilar experts see as the areas that require the most attention within biosimilar regulation.

You'll discover expert concerns and views on critical, market-shaping issues, and understand how they see biosimilar regulations evolving in the future in areas such as indication extrapolation, interchangeability, naming, terminology and the amount and type of clinical data needed to support regulatory approvals.

"The EMA has set the tone when it comes to biosimilar regulation. A pathway that, quite rightly, is seen as the gold standard pathway around the world." EU Biosimilars Expert.

Answering key questions

Get answers to key questions about the regulation of biosimilars, and how the area is set to evolve:

  • Approval timelines: The European Medicines Agency (EMA) takes - on average - 18 months to review a biosimilars application, while the U.S. Food and Drug Administration (FDA) took just ten months to approve Sandoz's Zarxio (filgrastim-sndz); is this EMA's timeline fixed, or can FDA-like improvements be made?
  • Analytical vs. Clinical? Will the FDA's focus on analytics continue to have an influence on global biosimilar regulations, or will agencies continue to adopt a more clinically focused approach like the EMA?
  • Naming: The FDA, EMA and World Health Organization (WHO) all have different proposals for naming conventions - what are the merits of each and how will this influence market dynamics?
  • Interchangeability: What's needed to demonstrate that a biosimilar is interchangeable? What will be the burden of proof? And will there be any commercial advantage? How this plays out in the future could ultimately come down to cost savings.
  • Extrapolation of indications: An area of fierce and continuing debate, with regulators taking differing views on the same product: will a consensus view emerge?
  • Emerging markets: Achieving wider patient access has led to a thriving "non-comparable biologics" market in certain emerging markets; will these markets continue to focus on patient access or align themselves with western regulatory models to gain wider access?

Top takeaways

  • Different paths to a common goal: Understand how differing regulators are approaching biosimilar regulation and know how this could impact product development strategies.
  • What's in a name? Confusion in naming conventions in the U.S. and Europe are compounded by a further proposal from the WHO. Understand the significance of this and how it might impact the industry.
  • Interchangeability: While the FDA has a clear remit to approve biosimilars as interchangeable, it has yet to publish guidance. In contrast, European countries make their own decisions on interchangeability and substitution, with the EMA having no remit in this area. The impact of switching to biosimilars can be significant, as demonstrated by developments in Denmark and Norway with biosimilar infliximab, but will it be the case in other markets?
  • Extrapolation across indications: While the scientific principles off indication extrapolation are accepted by most of the leading regulatory agencies, it's the application that sometimes differs. These differences of opinion create uncertainty for industry and have significant commercial implications.
  • It's not just about the U.S. and Europe: Get an international perspective by knowing how biosimilar regulation is evolving in other markets, including Australia, Japan and Canada, and evaluate the progress in developing robust biosimilar regulations in markets such as India, South Korea and Brazil.

Key issues explored

  • Will biosimilars ever be approved without clinical trial data to support the application, or will regulators always need some form of clinical data to satisfy any residual uncertainty?
  • Non-comparable biologics have found favour in certain emerging markets and patient needs are being met; could these markets move to meet the more stringent standards of the EU and U.S. and be considered biosimilars, or will ensuring patient access always be the number one priority?
  • Are regulators supporting the industry in achieving biosimilar approvals, or could they do more?
  • Is it now easier or more difficult to get approval for biosimilars, and does this vary by class of product and type of molecule?
  • What are the key differences in regulatory approaches around the world, and how are they impacting regulatory and clinical strategies?

A report based on expert US and EU industry knowledge

  • Hoss Dowlat is Vice President Regulatory Affairs, Global Strategy at PharmaBio Consulting.
  • Cecil Nick is Vice President (Biotechnology) at Parexel Consulting.
  • Gillian Woollett is Senior Vice President at Avalere
  • Florian Strohmaier is Director of Regulatory Affairs & Quality Management at a pure play biosimilar company based Germany.

Other experts interviewed for the purposes of this report - who requested anonymity due to the content of their comments - include a biosimilars expert working for a European biotech company, the global head of biologic strategy at a leading European biotech company, the global strategy and commercial lead for a US based biosimilars company, and industry experts from EU and US pharma companies. Emailed comments to specific questions were also received from a spokesperson at Germany's Paul Ehrlich Institute, one of Europe's leading regulatory bodies.

Back to Top