市場調査レポート

進化する市場におけるバイオシミラーの機会
Biosimilar Opportunities in an Evolving Market


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概要(日本語)

薬物療法の収益トップ10のうち、6製品は生物学的製剤となりました。これらの製品を合計した世界の売上額は、2012年に414億米ドルとなりました。

当レポートでは、世界のバイオシミラー製品の開発動向について調査分析し、主要製品の概要・製造業者・売上の推移、新たな開発動向、主要国の法規制環境、主要企業のプロファイルなどをまとめ、概略下記の構成でお届けいたします。

序文

エグゼクティブサマリー

バイオシミラー:バイオシミラーとは何か、また関心を持つ理由は?

  • バイオ医薬品とは何か?
  • バイオシミラーとバイオベターの定義

第1世代のバイオシミラー

  • エリスロポエチン
  • G-CSF
  • ホルモン
  • ヒトインスリン
  • インターフェロン
  • 次世代バイオシミラー生成:エタネルセプトおよびモノクロナール抗体

バイオシミラー規制

  • EU
  • 米国
  • その他の先進市場における規制
  • 新興市場における規制

主要企業

企業ディレクトリ

原文

Abstract

The long awaited promise of biosimilars takes another step to fulfilment with the first approval in Europe of high-value second generation products. But what products can be expected to follow, who is developing them and what are the hot prospects?

Biosimilars: another milestone passed

At the end of June 2013, the European Medicines Agency's Committee for Medical Products for Human Use issued a positive opinion for the first biosimilar version of Johnson & Johnson's infliximab for the treatment of rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis. For the two successful applicants, Celltrion and Hospira, this development passes a significant milestone for the whole biosimilar sector as the products are the first monoclonal antibody (mAb) therapies to reach a positive opinion following review via the EMA biosimilars regulatory pathway. This is an important event which heralds a new era of lower-cost biological therapies in Europe.

For J&J and its partners, the news is less welcome. Already under pressure from branded competitors in the TNF inhibitor market, it is no surprise that both developer and biosimilar companies will be assessing what share they may secure of its US$6.13 billion revenues.

The tip of a US$41 billion iceberg

While significant for J&J, infliximab is just the tip of the iceberg when it comes to the potential for biosimilars. In terms of revenue, six of the top ten pharmaceutical therapies are biological products, which have been targeted by biosimilar developers: Abbvie's Humira (adalimumab), Roche's MabThera (rituximab), Herceptin (trastuzumab) and Avastin (bevacizumab), Sanofi's Lantus (insulin glargine), and Johnson & Johnson's Remicade (infliximab). These products had combined global sales of US$41.4 billion in 2012. Also

of significant importance to biosimilar developers, with sales of US$4.2 billion in 2012 is Amgen's Enbrel (etanercept).

Open season: Branded industry gets in on the act

It may have taken a while, but the world's major pharmaceutical originators have recognised the potential for biosimilars. A number have disclosed their intentions and/or announced clinical trials in recent months. For example, in February 2013, Amgen announced plans to launch a portfolio of six new biosimilars beginning in 2017: adalimumab, infliximab, bevacizumab, trastuzumab, rituximab and cetuximab. Four of these projects form part of the

company's development agreement with Actavis. In June 2012, Merck KGaA and Dr Reddy's Laboratories announced a partnership to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies. Pfizer has been openly active in generics and biosimilars for some time. The company previously had a collaborative deal with Biocon for its insulin products, although this deal was concluded in March 2012. In May 2013, Pfizer began a Phase I trial with an infliximab biosimilar, PF-06438179. Many smaller biosimilar developers have the ambition but not the resources. The increasing interest from big Pharma will bring a welcome boost of expertise and funding to research and partnering.

The US Market: Not the elephant in the room

In any analysis of the pharma industry the US looms large - but not in biosimilars. The painfully slow progress to a regulatory pathway for biosimilars - still untried - has handed the initiative to others. The EU biosimilar regulations have been imitated widely in other countries, while the emphasis of biosimilar research sits firmly in Asia, notably India, China and South Korea. Of course, the big prize for all biosimilar manufacturers is the US market, which accounts for approximately 50% of the global value.

This report answers key questions:

  • Where is less competition to be found in the first phase of biosimilars in Epoetin and G-CSF?
  • Biosimilars are more widely available in emerging markets - what lessons can be learnt?
  • What are the latest State regulatory developments in the US and will they help or hinder?
  • Which are the companies to watch, and why?
  • Six companies are targeting Abbvie's Humira, who are they and what is the status of their research?

Foreword & Executive Summary

  • Biosimilars: What Are They and Why Are We Interested?
  • What Is A Biotech Drug?
  • Biosimilars and Biobetters Defined

Product Analysis

Each product review which follows covers, where appropriate,

  • Developer/Background
  • Mode of Action
  • Approvals
  • Competition within the Marketplace
  • Patents
  • Sales Trends

First Generation Biosimilars

Erythropoietin

  • Epogen/Eprex/Procrit (epoetin alfa)
  • Aranesp (darbepoetin alfa)
  • NeoRecormon (epoetin beta)
  • Mircera (methoxy polyethylene glycolepoetin beta)
  • Biosimilar Erythropoietin
    • Europe
    • USA
    • Rest of the World (Epoetin & Darbepoetin) G-CSF
  • Neupogen (filgrastim)
  • Neulasta (pegfilgrastim)
  • Neutrogin/Granocyte (lenograstim)
  • Biosimilar G-CSF
    • Europe (Filgrastim and Pegfilgrastim)
    • USA
    • Rest of the World

Human Growth Hormone (Somatropin)

  • Genotropin
  • Humatrope
  • Norditropin
  • Nutropin
  • Saizen
  • Biosimilar Somatropin
    • Europe
    • USA
    • Rest of the World

Follicle Stimulating Hormone

  • Gonal-f (follitropin alfa)
  • Biosimilar Follitropin Alfa
    • Europe
    • USA
    • Rest of the World

Human Insulin

  • Humulin (insulin [rDNA origin])
  • Humalog (insulin lispro)
  • Lantus (insulin glargine)
  • Apidra (insulin glulisine)
  • Levemir (insulin detemir)
  • NovoRapid & NovoMix (insulin aspart)
  • Biosimilar Human Insulin
    • Europe and USA
    • Rest of the World

Interferon

  • PegIntron (peginterferon alfa-2b)
  • Pegasys (pegylated-40K interferon alfa-2a)
  • Avonex (interferon beta-1a)
  • Rebif (interferon beta-1a)
  • Betaferon/Betaseron & Extavia (interferon beta-1b)
  • Biosimilar Interferon
    • Europe
    • Rest of the World

The Next Biosimilar Generation:

Etanercept and Monoclonal Antibodies

  • Enbrel (etanercept)
  • Biosimilar Etanercept
  • Remicade (infliximab)
  • Rituxan/MabThera (rituximab)
  • Herceptin (trastuzumab)
  • Humira (adalimumab)
  • Avastin (bevacizumab)
  • Erbitux (cetuximab)

Biosimilar mAb Development

  • Adalimumab
  • Bevacizumab
  • Cetuximab
  • Infliximab
  • Rituximab
  • Trastuzumab
  • Multiple mAb Development Agreements
    • Oncobiologics Biosimilar Collaborations

Biosimilar Regulation

  • European Union
  • United States

Regulation in Other Developed Markets

  • Australia
  • Canada
  • Japan
  • Singapore

Regulation in Emerging Markets

  • Brazil
  • India
  • Malaysia
  • Mexico
  • Peru
  • South Korea
  • Turkey

The Key Players

  • Sandoz
  • Teva
  • Hospira

Companies to Watch

  • Actavis
  • Biocon and Mylan
  • Celltrion
  • Ranbaxy

Major Pharma Companies - Recent Developments

  • Amgen
  • Merck & Co and Samsung Bioepis
  • Merck Serono and Dr Reddy's
  • Pfizer
  • Sanofi

Company Directory

List of Tables

  • Biosimilars Approved in the EU
  • Five-year Sales of Leading EPO Brands (US$ M)
  • Epogen US Patents
  • Epogen/Eprex/Procrit Sales, 2003-2012 (US$ M)
  • Aranesp US & EU Patents
  • Aranesp Sales, 2003-2012 (US$ M)
  • NeoRecormon/Epogin Sales, 2003-2012 (CHF & US$ M)
  • Mircera Sales, 2003-2012 (CHF & US$ M)
  • EU Marketing Authorisations for Biosimilar Eprex
  • Biosimilar Epoetin in Emerging Markets
  • Five-year Sales of Leading G-CSF Brands (US$ M)
  • Filgrastim US Patents
  • Neupogen Sales, 2003-2012 (US$ M)
  • Pegfilgrastim Patents
  • Neulasta Sales, 2003-2012 (US$ M)
  • Neutrogin/Granocyte Sales, 2003-2012 (CHF & US$ M)
  • EU Marketing Authorisations for Biosimilar Filgrastim
  • Biosimilar G-CSF in Emerging Markets
  • Five-year Sales of Leading Somatropin Brands (US$ M)
  • Gentropin Sales, 2003-2012 (US$ M)
  • Humatrope Sales, 2003-2012 (US$ M)
  • Norditropin Sales, 2003-2012 (DKK & US$ M)
  • Nutropin Sales, 2003-2012 (US$ M)
  • Saizen Sales, 2003-2012 (EUR & US$ M)
  • Biosimilar HGH in Emerging Markets
  • Gonal-f US Patents
  • Gonal-f Sales, 2003-2012 (EUR & US$ M)
  • Biosimilar FSH in Emerging Markets
  • Five-Year Sales of Leading Insulin Brands (US$ M)
  • Humulin Sales, 2003-2012 (US$ M)
  • Humalog US Patents
  • Humalog Sales, 2003-2012 (US$ M)
  • Lantus US Patents
  • Lantus Sales, 2003-2012 (EUR & US$ M)
  • Apidra US Patents
  • Apidra Sales, 2008-2012 (EUR & US$ M)
  • Levemir US Patents
  • Levemir Sales, 2005-2012 (DKK & US$ M)
  • NovoRapid & NovoMix US Patents
  • NovoRapid & NovoMix Sales, 2005-2012 (DKK & US$ M)
  • Five-year Sales of Leading Interferon Alfa Brands (US$ M)
  • Five-year Sales of Leading Interferon Beta Brands (US$ M)
  • PegIntron US Patents
  • PegIntron Sales, 2003-2012 (US$ M)
  • Pegasys US Patents
  • Pegasys Sales, 2003-2012 (CHF & US$ M)
  • Avonex US Patents
  • Avonex Sales 2003-2012 (US$ M)
  • Rebif Sales, 2003-2012 (EUR & US$ M)
  • Betaferon/Betaseron & Extavia Sales, 2003-2012 (EUR & US$ M)
  • Biosimilar Interferon in Emerging Markets
  • Five-Year Sales of Enbrel and Leading Monoclonal Antibodies (US$ M)
  • Enbrel US Patents
  • Enbrel Sales by Company, 2003-2012 (US$ M)
  • Remicade US Patents
  • Remicade Sales by Company, 2003-2012 (US$ M)
  • Rituxan/MabThera Sales, 2003-2012 (CHF & US$ M)
  • Herceptin US Patents
  • Herceptin Sales, 2003-2012 (CHF & US$)
  • Humira US Patents
  • Humira Sales by Company, 2003-2012 (US$ M)
  • Avastin Sales, 2004-2012 (CHF & US$ M)
  • Erbitux Sales by Company, 2004-2012 (EUR & US$ M)

About the Author

The report has been researched and written by experienced independent market analyst, Karen Holmes. Karen has over 17 years pharmaceutical and healthcare market analysis experience. Among her many reports for Espicom are:

  • Hospital Generic Drugs: Prospects for Generics and Biosimilars
  • The Indian Pharmaceutical Industry: Expansion & Ambitions
  • Understanding Brazil's Regional Health Markets
  • The Complete Guide to Companion Diagnostics

About the Publisher

Espicom Business Intelligence is a leading provider of specialist pharmaceutical market information. Based in the UK and with over 30 years of experience, the company produces a broad range of business and therapy titles, with a particular emphasis on the global generics market, and is uniquely placed to publish this report. Espicom is part of Business Monitor International.

Table of Contents

Foreword

Executive Summary

Biosimilars: What Are They And Why Are We Interested?

  • What Is A Biotech Drug?
  • Biosimilars And Biobetters Defined

First Generation Biosimilars

  • Erythropoietin
    • Epogen/Eprex/Procrit (epoetin alfa)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Aranesp (darbepoetin alfa)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • NeoRecormon (epoetin beta)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Sales Trends
    • Mircera (methoxy polyethylene glycol-epoetin beta)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Sales Trends
      • Biosimilar Erythropoietin
      • Europe
      • USA
      • Rest of the World
        • Epoetin
        • Darbepoetin
  • G-CSF
    • Neupogen (filgrastim)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Neulasta (pegfilgrastim)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Neutrogin/Granocyte (lenograstim)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Sales Trends
    • Biosimilar G-CSF
      • Europe
        • Filgrastim
        • Pegfilgrastim
      • USA
      • Rest of the World
  • Hormones
    • Human Growth Hormone (Somatropin)
      • Genotropin
      • Humatrope
      • Norditropin
      • Nutropin
      • Saizen
    • Biosimilar Somatropin
      • Europe
      • USA
      • Rest of the World
    • Follicle Stimulating Hormone
    • Gonal-f (follitropin alfa)
      • Mode of Action
      • Approvals
      • Patents
      • Sales Trends
    • Biosimilar Follitropin Alfa
      • Europe
      • USA
      • Rest of the World
  • Human Insulin
    • Humulin (insulin [rDNA origin])
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Sales Trends
    • Humalog (insulin lispro)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Lantus (insulin glargine)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Apidra (insulin glulisine)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Levemir (insulin detemir)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • NovoRapid & NovoMix (insulin aspart)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Biosimilar Human Insulin
      • Europe and USA
      • Rest of the World
  • Interferon
    • PegIntron (peginterferon alfa-2b)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Pegasys (pegylated-40K interferon alfa-2a)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Avonex (interferon beta-1a)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Rebif (interferon beta-1a)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Sales Trends
    • Betaferon/Betaseron & Extavia (interferon beta-1b)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Biosimilar Interferon
      • Europe
      • Rest of the World
  • The Next Biosimilar Generation: Etanercept and Monoclonal Antibodies
    • Enbrel (etanercept)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
      • Biosimilar Etanercept
    • Remicade (infliximab)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Rituxan/MabThera (rituximab)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Herceptin (trastuzumab)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Breast Cancer
      • Gastric Cancer
      • Patents
      • Sales Trends
    • Humira (adalimumab)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Avastin (bevacizumab)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Erbitux (cetuximab)
      • Mode of Action
      • Approvals
      • Competition within the Marketplace
      • Patents
      • Sales Trends
    • Biosimilar mAb Development
      • Adalimumab
      • Bevacizumab
      • Cetuximab
      • Infliximab
      • Rituximab
      • Trastuzumab
      • Multiple mAb Development Agreements
        • Oncobiologics Biosimilar Collaborations

Biosimilar Regulation

  • European Union
  • United States
    • Legislation Progress in the United States
      • Virginia Passes Biosimilar Legislation
      • Mississippi Rejects Legislation
  • Regulation in Other Developed Markets
    • Australia
    • Canada
    • Japan
    • Singapore
  • Regulation in Emerging Markets
    • Brazil
    • India
    • Malaysia
    • Mexico
    • Peru
    • South Korea
    • Turkey

The Key Players

  • Sandoz
  • Teva
  • Hospira
  • Companies to Watch
    • Actavis
    • Biocon and Mylan
    • Celltrion
    • Ranbaxy
  • Major Pharma Companies - Recent Developments
    • Amgen
    • Merck & Co and Samsung Bioepis
    • Merck Serono and Dr Reddy's
    • Pfizer
    • Sanofi

Company Directory

List of Tables

  • Biosimilars Approved in the EU
  • Five-year Sales of Leading EPO Brands (US$ Million)
  • Epogen US Patents
  • Epogen/Eprex/Procrit Sales, 2003-2012 (US$ Million)
  • Aranesp US & EU Patents
  • Aranesp Sales, 2003-2012 (US$ Million)
  • NeoRecormon/Epogin Sales, 2003-2012 (CHF & US$ Million)
  • Mircera Sales, 2003-2012 (CHF & US$ Million)
  • EU Marketing Authorisations for Biosimilar Eprex
  • Biosimilar Epoetin in Emerging Markets
  • Five-year Sales of Leading G-CSF Brands (US$ Million)
  • Filgrastim US Patents
  • Neupogen Sales, 2003-2012 (US$ Million)
  • Pegfilgrastim Patents
  • Neulasta Sales, 2003-2012 (US$ Million)
  • Neutrogin/Granocyte Sales, 2003-2012 (CHF & US$ Million)
  • EU Marketing Authorisations for Biosimilar Filgrastim
  • Biosimilar G-CSF in Emerging Markets
  • Five-year Sales of Leading Somatropin Brands (US$ Million)
  • Gentropin Sales, 2003-2012 (US$ Million)
  • Humatrope Sales, 2003-2012 (US$ Million)
  • Norditropin Sales, 2003-2012 (DKK & US$ Million)
  • Nutropin Sales, 2003-2012 (US$ Million)
  • Saizen Sales, 2003-2012 (EUR & US$ Million)
  • Biosimilar HGH in Emerging Markets
  • Gonal-f US Patents
  • Gonal-f Sales, 2003-2012 (EUR & US$ Million)
  • Biosimilar FSH in Emerging Markets
  • Five-Year Sales of Leading Insulin Brands (US$ Million)
  • Humulin Sales, 2003-2012 (US$ Million)
  • Humalog US Patents
  • Humalog Sales, 2003-2012 (US$ Million)
  • Lantus US Patents
  • Lantus Sales, 2003-2012 (EUR & US$ Million)
  • Apidra US Patents
  • Apidra Sales, 2008-2012 (EUR & US$ Million)
  • Levemir US Patents
  • Levemir Sales, 2005-2012 (DKK & US$ Million)
  • NovoRapid & NovoMix US Patents
  • NovoRapid & NovoMix Sales, 2005-2012 (DKK & US$ Million)
  • Five-year Sales of Leading Interferon Alfa Brands (US$ Million)
  • Five-year Sales of Leading Interferon Beta Brands (US$ Million)
  • PegIntron US Patents
  • PegIntron Sales, 2003-2012 (US$ Million)
  • Pegasys US Patent
  • Pegasys Sales, 2003-2012 (CHF & US$ Million)
  • Avonex US Patents
  • Avonex Sales 2003-2012 (US$ Million)
  • Rebif Sales, 2003-2012 (EUR & US$ Million)
  • Betaferon/Betaseron & Extavia Sales, 2003-2012 (EUR & US$ Million)
  • Biosimilar Interferon in Emerging Markets
  • Five-Year Sales of Enbrel and Leading Monoclonal Antibodies (US$ Million)
  • Enbrel US Patents
  • Enbrel Sales by Company, 2003-2012 (US$ Million)
  • Remicade US Patents
  • Remicade Sales by Company, 2003-2012 (US$ Million)
  • Rituxan/MabThera Sales, 2003-2012 (CHF & US$ Million)
  • Herceptin US Patents
  • Herceptin Sales, 2003-2012 (CHF & US$ Million)
  • Humira US Patents
  • Humira Sales by Company, 2003-2012 (US$ Million)
  • Avastin Sales, 2004-2012 (CHF & US$ Million)
  • Erbitux Sales by Company, 2004-2012 (EUR & US$ Million)

List of Figures

  • Leading EPO Brands, Global Sales 2003-2012 (%)
  • Leading EPO Brands, Revenue Share 2012 (%)
  • Epogen/Eprex/Procrit Sales, 2003-2012 (US$ Million)
  • Aranesp Sales, 2003-2012 (US$ Million)
  • NeoRecormon/Epogin Sales, 2003-2012 (US$ Million)
  • Mircera Sales, 2003-2012 (US$ Million)
  • Leading G-CSF Brands, Global Sales 2003-2012 (%)
  • Leading G-CSF Brands, Revenue Share 2012 (%)
  • Neupogen Sales, 2003-2012 (US$ Million)
  • Neulasta Sales, 2003-2012 (US$ Million)
  • Neutrogin/Granocyte Sales, 2003-2012 (US$ Million)
  • Leading Somatropin Brands, Global Sales 2003-2012 (US$ Million)
  • Leading Somatropin Brands, Revenue Share 2012 (%)
  • Gentropin Sales, 2003-2012 (US$ Million)
  • Humatrope Sales, 2003-2012 (US$ Million)
  • Norditropin Sales, 2003-2012 (US$ Million)
  • Nutropin Sales, 2003-2012 (US$ Million)
  • Saizen Sales, 2003-2012 (US$ Million)
  • Gonal-f Sales, 2003-2012 (US$ Million)
  • Leading Insulin Brands, Global Sales 2005-2012 (US$ Million)
  • Humulin Sales, 2003-2012 (US$ Million)
  • Humalog Sales, 2003-2012 (US$ Million)
  • Lantus Sales, 2003-2012 (US$ Million)
  • Apidra Sales, 2008-2012 (US$ Million)
  • Levemir Sales, 2005-2012 (US$ Million)
  • NovoRapid & NovoMix Sales, 2005-2012 (US$ Million)
  • PegIntron Sales, 2003-2012 (US$ Million)
  • Pegasys Sales, 2003-2012 (US$ Million)
  • Avonex Sales, 2003-2012 (US$ Million)
  • Rebif Sales, 2003-2012 (US$ Million)
  • Betaferon/Betaseron & Extavia Sales, 2003-2012 (US$ Million)
  • Enbrel Sales, 2003-2012 (US$ Million)
  • Remicade Sales, 2003-2012 (US$ Million)
  • Rituxan/MabThera Sales, 2003-2012 (US$ Million)
  • Herceptin Sales, 2003-2012 (US$ Million)
  • Humira Sales, 2003-2012 (US$ Million)
  • Avastin Sales, 2004-2012 (US$ Million)
  • Erbitux Sales, 2004-2012 (US$ Million)

商品情報

商品コード:ES229669

出版日:2013年8月

言語:英語

ページ情報:
113 Pages


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