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市场调查报告书

进入欧洲的生物仿制药市场

Biosimilars Market Access in the EU

出版商 Datamonitor Healthcare 商品编码 604015
出版日期 内容资讯 英文 137 Pages
商品交期: 最快1-2个工作天内
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进入欧洲的生物仿制药市场 Biosimilars Market Access in the EU
出版日期: 2018年01月19日内容资讯: 英文 137 Pages
简介

生物仿制药已欧洲普及10年以上、但多数生物制剂的治疗费减少了可提供的机会。EU加盟国为了减少医疗制度的巨大费用、在进入市场、价格、补偿等方面的检查都是十分重要的。

本报告针对EU生物仿制药市场进行调查、提供市场现况、智慧财产与法律问题、面对的课题、国家分类动向、今后预测。

摘要整理

生物仿制药法规

  • 见解与策略建议
  • 认可生物仿制药的欧洲规范已普及10年以上
  • 欧洲委员会已确立认可EU生物仿制药法律基础
  • EMA发表生物仿制药认可条件指南
  • 生物仿制药开发法规条件已成为指南
  • 适应症扩大以涵盖数据为基准
  • EU互换性概念与美国不同
  • EU初次认可的生物仿制药分子为Ominitrope
  • EU初次认可的单株抗体为Inflectra/Remisma
  • EMA认可分散于14级的38种生物仿制药
  • 相关情报

智慧财产与法律课题

  • 见解与策略建议
  • 生物仿制药有许多智慧财产与法律课题
  • 欧洲专利组织提供加盟国的专利申请
  • 统一专利系统建立加盟国单一专利制度
  • 生物仿制药开发共同特征是发起者专利问题
  • 相关情报

命名与商标

  • 见解与策略建议
  • 生物仿制药命名与商标欧洲各国统一
  • 相关情报

代用与变换

  • 见解与策略建议
  • 生物仿制药互换性、代用、变换EMA定义中立
  • 变换与代用的EU各国现在立场
  • 相关情报

促进生物仿制药摄取的工具

  • 见解与策略建议
  • 促进生物仿制药的各种工具
  • 相关人员教育不可缺少
  • 相关情报

支付者见解与动向

法国

德国

义大利

西班牙

英国

生物仿制药差别

调查方法

目录
Product Code: DMKC0187738

Overview

Biosimilars have been available in Europe for over a decade, and have offered the opportunity to vastly reduce the cost of treatment for a large number of biologic agents. In order to deliver significant savings to the healthcare structure of each individual EU member state, a careful inspection of the market access, pricing, and reimbursement mechanisms in force in each region is paramount. An in-depth knowledge of what drives payer and physician decision-making on biosimilar use is crucial for biosimilar developers wishing to design market access strategies uniquely tailored to the specific demands in each EU member state.

This analysis summarizes key information on the process of biosimilar approval in Europe, along with associated challenges, and provides highlights on country-specific market access, pricing, and reimbursement mechanisms which drive biosimilar uptake or prove a barrier to their entrance.

TABLE OF CONTENTS

EXECUTIVE SUMMARY

  • A regulatory pathway governing biosimilars in Europe has existed for over a decade
  • Biosimilar developers need to overcome a plethora of IP and legal obstacles
  • Biosimilar naming and labeling in the EU is uniform
  • European countries have comparable views on substitution and switching
  • Global trends in biosimilar uptake in the five major EU markets
  • Gain-sharing and CQUIN targets are key payer measures to drive biosimilar uptake in the UK
  • Prescribing quotas and contracting for preferred biosimilars targets are key payer measures to drive biosimilar uptake in Germany
  • Hospital-level price differentials between expensive liste-en-sus therapies and tender prices are a key payer measure to drive biosimilar uptake in France
  • Biosimilar prescription quotas and regional negotiations are key payer measures to drive biosimilar uptake in Spain
  • Budget constraints are key payer measures to drive biosimilar uptake in Italy

BIOSIMILAR REGULATORY PATHWAY

  • Datamonitor Healthcare insights and strategic recommendations
  • The European regulatory pathway for biosimilar approval has been available for over a decade
  • The European Commission has established the legal basis for the approval of biosimilars in the EU
  • The EMA has released guidance on biosimilar approval requirements
  • The regulatory requirements for biosimilar development are outlined in the guideline
  • Indication extrapolation is based on a comprehensive data package
  • The concept of interchangeability in the EU differs from the US
  • Omnitrope was the first biosimilar molecule approved in the EU
  • Inflectra/Remsima is the first biosimilar monoclonal antibody approved in the EU
  • The EMA has approved 38 biosimilar medicines in 14 different classes
  • Bibliography

INTELLECTUAL PROPERTY AND LEGAL ISSUES

  • Datamonitor Healthcare insights and strategic recommendations
  • There are numerous intellectual property and legal issues associated with biosimilars
  • The European Patent Organisation issues bundles of patents to its member states
  • The Unitary Patent system will create a single-patent system for EU member states
  • Challenging originator molecule patents is a common feature of biosimilar development
  • Bibliography

NAMING AND LABELING

  • Datamonitor Healthcare insights and strategic recommendations
  • Biosimilar naming and labeling is uniform across European countries
  • Bibliography

SUBSTITUTION AND SWITCHING

  • Datamonitor Healthcare insights and strategic recommendations
  • There are nuances in the EMA definitions of biosimilar interchangeability, substitution, and switching
  • Current position of EU countries on switching and substitution
  • Bibliography

PAYER TOOLS TO DRIVE BIOSIMILAR UPTAKE

  • Datamonitor Healthcare insights and strategic recommendations
  • Payers implement a wide variety of tools to drive biosimilar uptake
  • Educating stakeholders is crucial for biosimilar uptake

PAYER VIEWS AND TRENDS

  • Datamonitor Healthcare insights and strategic recommendations
  • Biosimilar uptake varies across EU markets as the EMA does not determine interchangeability
  • There are country-specific differences in biosimilar pricing, but the need for a substantial discount is universal
  • Hospitals continue to procure both biosimilars and originators
  • Availability of Herceptin and Rituxan in a patent-protected SC formulation is only a minor barrier to biosimilar entry
  • Bibliography

FRANCE

  • Datamonitor Healthcare insights and strategic recommendations
  • The TC evaluates new drugs and sets ASMR ratings, with impacts on drug pricing
  • CEPS requires a reduction in the reimbursement price of biologics dispensed outside of hospitals upon biosimilar entry
  • Payer measures to drive uptake
  • Bibliography

GERMANY

  • Datamonitor Healthcare insights and strategic recommendations
  • Manufacturers are free to set biosimilar prices in Germany
  • Payer measures to drive uptake
  • Uptake of most biosimilar products in Germany has been high
  • Bibliography

ITALY

  • Datamonitor Healthcare insights and strategic recommendations
  • AIFA considers all biosimilar applications in Italy
  • AIFA issued a concept paper on biosimilars to clarify the legal framework around biosimilar procurement and use
  • Biosimilars in Italy are required to offer at least 20% discount on the price of their originators
  • Drivers and resistors to biosimilar use in Italy
  • The prevalent use of biosimilars in Italy is in biologic-naive patients, but switching experienced patients onto a biosimilar also occurs
  • The key drivers to biosimilar uptake in Italy are budget constraints and guidelines encouraging the use of cheaper options
  • Certain regions set provisions to regulate biologic prescription and control expenditure
  • Bibliography

SPAIN

  • Datamonitor Healthcare insights and strategic recommendations
  • Biosimilars in Spain should be priced 30% lower than their branded counterpart
  • Payer measures to drive uptake
  • Bibliography

UK

  • Datamonitor Healthcare insights and strategic recommendations
  • The UK has a free pricing system for biosimilars
  • CCGs are responsible for a large proportion of commissioning but NHS England is the payer for biosimilars in oncology
  • Tendering and procurement in the UK is a complex process
  • Biosimilars in the UK are not viewed as interchangeable
  • Payer measures to drive biosimilar uptake in the UK
  • Biosimilar adoption has been a relative success in the UK
  • Biosimilar adoption varies depending on region and molecule
  • Bibliography

BIOSIMILAR DIFFERENTIATION

  • Added services are viewed as valuable by some payers
  • Availability of pre-filled infusion bags is a valuable service to UK payers
  • Product presentation and packaging may matter more than expected
  • Identity of the company matters but consistency of supply is more important
  • Bibliography

METHODOLOGY

  • Primary research

LIST OF FIGURES

  • Figure 1: Drivers and resistors to biosimilar use in France
  • Figure 2: Drivers and resistors to biosimilar use in Germany
  • Figure 3: Drivers and resistors to biosimilar use in Italy
  • Figure 4: Drivers and resistors to biosimilar use in Spain
  • Figure 5: Drivers and resistors to biosimilar use in the UK

LIST OF TABLES

  • Table 1: List of biosimilar guidelines issued by the EMA
  • Table 2: Biosimilars with marketing authorization in the EU by the EC, following an assessment by the EMA's CHMP, 2006-17
  • Table 3: EMA definitions of biosimilar interchangeability, substitution, and switching
  • Table 4: Overview of the general opinions on automatic substitution and switching in the five major EU markets
  • Table 5: Position statements on automatic substitution and switching: EU-wide organizations
  • Table 6: Position statements on automatic substitution and switching in the UK
  • Table 7: Position statements on automatic substitution and switching in Germany
  • Table 8: Position statements on automatic substitution and switching in France
  • Table 9: Position statements on automatic substitution and switching in Italy
  • Table 10: Position statements on automatic substitution and switching in Spain
  • Table 11: Biosimilar market access overview in the five major EU markets
  • Table 12: ASMR ratings and pricing implications
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