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バイオシミラー薬剤開発における治験戦略

Clinical Trial Strategies in Biosimilar Drug Development

発行 Datamonitor Healthcare 商品コード 573565
出版日 ページ情報 英文 149 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=109.06円で換算しております。
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バイオシミラー薬剤開発における治験戦略 Clinical Trial Strategies in Biosimilar Drug Development
出版日: 2017年10月13日 ページ情報: 英文 149 Pages
概要

ブロックバスター生物学的薬剤の多くが特許失効を迎える中、バイオシミラーオプションの臨床開発プログラムが急速に進められています。

当レポートでは、バイオシミラー薬剤開発における治験戦略について調査し、バイオシミラー治験の世界的動向、適応別動向、今後の見通しなどをまとめています。

エグゼクティブサマリー

治験戦略の概要

  • バイオシミラー開発は多くのリスクを伴うが潜在的リターンは大きい
  • バイオシミラー認可経路の比較
  • 適用外挿に対する見解は帰省当局により異なる
  • FDAは互換性を求めるバイオシミラー治験依頼者に向けた要求事項を概説している
  • 参考

バイオシミラー治験における世界の動向

  • バイオシミラー候補の治験数は増加している
  • バイオシミラー治験数の増加はブランド薬特許の失効により牽引されている
  • バイオシミラー開発プロジェクトの高い比率は規制された市場を標的としている
  • 幅広い業界スポンサーがバイオシミラー臨床開発に携わっている
  • バイオシミラー治験依頼者は慎重に治験実施場所を選択している
  • トップ3のバイオシミラー開発の治療領域は自己免疫疾患、炎症、癌、内分泌/心臓
  • バイオシミラー治験依頼者は度の疾患が治験対象となるべきか慎重に選択している

自己免疫/炎症バイオシミラー治験動向

  • 自己免疫/炎症はバイオシミラー開発会社が最も標的とする治療分野
  • 規制された市場における標的分子の多くは抗TNF治療
  • 自己免疫/炎症への適応のために治験を実施したバイオシミラー治験依頼者は非常に競争が激しい
  • バイオシミラーの自己免疫/炎症適応の分析
  • 参考

癌のバイオシミラー治験動向

  • 癌はバイオシミラー開発会社が標的とする治療分野の第2位
  • 割かく癌におけるバイオシミラー開発スポンサーは3つのブロックバスターMaBを標的に
  • 癌の適応で治験を実施するバイオシミラー治験依頼者分析
  • 癌のバイオシミラー治験のための適切な標的人口の選定は重要
  • 欧州は癌バイオシミラーの治験サイトを最大数保有
  • 参考

内分泌/腎臓バイオシミラー動向

  • 内分泌/腎臓がバイオシミラー開発会社が標的とする治療分野の第3位
  • インスリン製品およびエリスロポエチン刺激剤は内分泌/腎臓分野のバイオシミラー開発にとっての最も参考となる選択
  • 内分泌/腎臓
  • 内分泌/腎臓適応にて治験を実施するバイオシミラー治験依頼者の分析
  • 米国は内分泌/腎臓バイオシミラーの臨床開発において最も活発な地域
  • 参考

治療分野へのバイオシミラー治験動向

  • 眼科におけるバイオシミラー標的はモノクローナル抗体ranibizumab
  • 生殖医療におけるバイオシミラー標的にはホリトロピンアルファ
  • バイオシミラー治験依頼者は血液、C型肝炎、多発性硬化症におけるバイオシミラーを開発している
  • 参考

遺第3相に移行する研究デザインとバイオシミラーの互換性

  • 研究移行データのニーズがある
  • FDAは互換性に関する問題に対処するために互換性ガイドラインの草案を作成
  • バイオシミラー治験依頼者はブランドとバイオシミラーとの間の安全性と有効性を評価するために実施
  • バイオシミラー
  • 参考

付録

図表

目次
Product Code: DMKC0179970

As the patent cliff for many blockbuster biologic therapies is approaching, clinical development programs for biosimilar options to those therapies are emerging at a rapid pace. Among the key areas of development is biologics in the autoimmune/inflammation, oncology, and endocrinology/nephrology space. Sponsors of biosimilar projects are carefully designing their trials, assessing the most suitable target populations, and geography.

The concept of interchangeability in the US, where a reference product and a biosimilar are considered freely interchangeable, is not seen in Europe or other developed regions. By gaining an interchangeability status, a biosimilar may greatly enhance its uptake, however the FDA requires that the applicant should strictly adhere to the recently issued Guidelines on Interchangeability. The guideline asks sponsors to conduct a tailored clinical investigation containing multiple elements of switching between the brand and biosimilar as a proof that switching is a safe practice. This report outlines the approaches to switching that various sponsors have adopted prior to the availability of the FDA guidance, and after its publication.

TABLE OF CONTENTS

EXECUTIVE SUMMARY

  • The volume of biosimilar clinical trials initiated globally is growing
  • Autoimmune/inflammation is the top targeted area for biosimilar development
  • Oncology biosimilars come as a second choice for biosimilar developers
  • Biosimilars in endocrinology/nephrology are progressing through the pipeline
  • Some biosimilar sponsors also target therapy areas such as ophthalmology, reproductive health, and multiple sclerosis
  • Biosimilar sponsors may employ switching designs in their Phase III trials to demonstrate interchangeability

OVERVIEW OF CLINICAL TRIAL STRATEGIES

  • Biosimilar development is associated with many risks, but potential high returns
  • Comparison of biosimilar approval pathways
  • Views on indication extrapolation differ among regulatory authorities
  • The FDA outlined requirements for biosimilar sponsors seeking interchangeability status
  • Bibliography

GLOBAL TRENDS IN BIOSIMILAR CLINICAL TRIALS

  • The total number of clinical trials for biosimilar candidates has been incrementally increasing
  • The growth in biosimilar clinical trial volume is driven by the expiration of branded drug patents
  • A higher proportion of bioisimilar development projects is targeted towards regulated markets
  • A diverse range of industry sponsors are involved in biosimilar clinical development
  • Biosimilar sponsors carefully choose trial location regions
  • The top three therapy areas for the development of biosimilars are autoimmune and inflammation, oncology, and endocrinology/nephrology
  • Biosimilar sponsors carefully choose which disease indications to study in clinical trials
  • Bibliography

AUTOIMMUNE/INFLAMMATION BIOSIMILAR TRIAL TRENDS

  • Autoimmune/inflammation is the therapeutic area most often targeted by biosimilar developers
  • The most often targeted molecules in regulated markets are anti-TNF therapies
  • Biosimilar sponsors initiating trials in A/I indications are joining a highly competitive space
  • Analysis of tested A/I indications for biosimilars
  • Europe is the most active clinical trial hub for A/I biosimilar clinical development
  • Bibliography

ONCOLOGY BIOSIMILAR TRIAL TRENDS

  • Oncology is the second most often targeted therapeutic area by biosimilar developers
  • Sponsors developing biosimilars in oncology are targeting three blockbuster Mabs
  • Analysis of biosimilar sponsors conducting clinical trials in oncology indications
  • Choosing an appropriate target population for oncology biosimilar trials is essential
  • Europe has the highest number of clinical trial sites for oncology biosimilars
  • Bibliography

ENDOCRINOLOGY/NEPHROLOGY BIOSIMILAR TRIAL TRENDS

  • Endocrinology/nephrology is the third most often targeted therapeutic area by biosimilar developers
  • Insulin products and erythropoetin stimulating agents are among the top reference choices for developers of biosimilars in
  • endocrinology/nephrology
  • Analysis of biosimilar sponsors conducting clinical trials in endocrinology/nephrology indications
  • The US is the most active region chosen for the clinical development of endocrinology/nephrology biosimilars
  • Bibliography

BIOSIMILAR TRIAL TRENDS IN OTHER THERAPEUTIC AREAS

  • A key biosimilar target in ophthalmology is the monoclonal antibody ranibizumab
  • A key biosimilar target in reproductive health is follitropin alfa
  • Biosimilar sponsors also develop biosimilars in hematology, hepatitis C, and multiple sclerosis
  • Bibliography

PHASE III SWITCHING STUDY DESIGNS AND BIOSIMILAR INTERCHANGEABILITY

  • There is a need for data from switching studies
  • The FDA has issued draft interchangeability guidelines to shed some light on the issue of interchangeability
  • Biosimilar sponsors may conduct switching studies to assess safety and effectiveness of switching between the brand and
  • the biosimilar
  • Bibliography

APPENDIX

  • Scope
  • Methodology

LIST OF FIGURES

  • Figure 1: Clinical trial volume over time, per trial phase, 2011-17
  • Figure 2: Volume of biosimilar clinical trial starts by geographic market type, all therapeutic areas, 2011-17
  • Figure 3: Volume of biosimilar trials per wave in all regions, 2011-17
  • Figure 4: Volume of biosimilar trials per wave, in regulated markets and ROW, 2011-17
  • Figure 5: Biosimilar clinical trial starts, all therapeutic areas, 2011-17, by trial phase
  • Figure 6: Clinical trials in the regulated markets and in ROW regions: top 10 sponsors by total number, 2011-17
  • Figure 7: Volume of biosimilar clinical trials by sponsor and phase: top 15 sponsors, all regions, 2011-17
  • Figure 8: Volume of biosimilar clinical trials in the regulated markets and ROW, by country
  • Figure 9: Biosimilar clinical trial location by sponsor in the regulated markets: top 15 sponsors, by trial volume
  • Figure 10: Biosimilar clinical trial location by sponsor in ROW: top 15 sponsors, by trial volume
  • Figure 11: Volume of biosimilar clinical trials, by therapeutic area
  • Figure 12: Volume of clinical trial starts by therapeutic area in the regulated markets and ROW
  • Figure 13: Proportion of clinical trial volume within a specific therapeutic area, regulated markets, 2011-17
  • Figure 14: Overall biosimilar clinical trial volume by choice of reference product (top 10 products)
  • Figure 15: Volume of clinical trials targeting a specific disease indication: top 10 indications
  • Figure 16: Volume of Phase I and Phase III biosimilar clinical trials targeting a specific disease indication, regardless of region: top 5 indications per phase
  • Figure 17: Volume of Phase IV biosimilar clinical trials targeting a specific disease indication, regardless of region: top 10 indications
  • Figure 18: Volume of biosimilar clinical trial starts by geographic market type, A/I indications, 2011-17
  • Figure 19: Volume of biosimilar clinical trial starts by geographic market type, A/I indications
  • Figure 20: Choice of reference product for A/I biosimilar clinical trials, all regions and phases
  • Figure 21: Number of biosimilar trials in A/I indications, per reference product and phase
  • Figure 22: Clinical trial volume of biosimilar programs in A/I diseases, by start year, 2011-17
  • Figure 23: Top biosimilar sponsors in A/I indications, per phase
  • Figure 24: Map of the pipeline progress of the top 10 biosimilar developers in the A/I space in the EU, US, and Japan
  • Figure 25: Volume of A/I clinical trial starts per sponsor, per reference molecule: top sponsors
  • Figure 26: Status and sponsors of multinational Phase III A/I biosimilars programs
  • Figure 27: Volume of Phase III trials for biosimilars of each A/I reference product in the regulated markets
  • Figure 28: Status of Phase III A/I biosimilar trials for the top 10 sponsors in the regulated markets
  • Figure 29: Disease indications for Phase III trials of A/I biosimilars in the regulated markets, by reference product an sponsor
  • Figure 30: Indications studied in post-marketing trials of infliximab biosimilars for the regulated markets
  • Figure 31: Volume of biosimilar A/I clinical trial sites in the regulated markets and in ROW
  • Figure 32: Clinical trial locations for A/I biosimilar candidates per region
  • Figure 33: Volume of biosimilar clinical trial starts by geographic market type, oncology indications, 2011-17
  • Figure 34: Volume of biosimilar clinical trial starts by geographic market type, oncology indications
  • Figure 35: Choice of reference product for oncology biosimilar clinical trials, all regions and phases
  • Figure 36: Number of biosimilar trials in oncology indications, per reference product and phase
  • Figure 37: Clinical trial volume of biosimilar programs in oncology, by start year, 2011-17
  • Figure 38: Top biosimilar sponsors in oncology indications, per phase
  • Figure 39: Map of the pipeline progress of the top biosimilar developers in the oncology space in EU, US, and Japan: top four reference molecules
  • Figure 40: Volume of oncology clinical trial starts per sponsor, per reference molecule: top sponsors
  • Figure 41: Status and sponsors of oncology Phase III biosimilars programs targeting the regulated markets
  • Figure 42: Volume of Phase III trials for biosimilars of each oncology reference product in the regulated markets
  • Figure 43: Disease indications for Phase III trials of oncology biosimilars in the regulated markets, by reference product and sponsor
  • Figure 44: Volume of biosimilar oncology clinical trial sites in the regulated markets and in ROW
  • Figure 45: Clinical trial locations for oncology biosimilar candidates per region
  • Figure 46: Volume of biosimilar clinical trial starts by geographic market type, endocrinology/nephrology indications, 2011-17
  • Figure 47: Volume of biosimilar clinical trial starts by geographic market type, endocrinology/nephrology indications
  • Figure 48: Choice of reference product for endocrinology/nephrology biosimilar clinical trials, all regions and phases
  • Figure 49: Number of biosimilar trials in endocrinology/nephrology indications, per reference product and phase
  • Figure 50: Clinical trial volume of biosimilar programs in endocrinology/nephrology indications, by start year, 2011-17
  • Figure 51: Top biosimilar sponsors in endocrinology/nephrology indications, per phase
  • Figure 52: Map of the pipeline progress of the top biosimilar developers in the endocrinology/nephrology space in the EU, US or Japan
  • Figure 53: Volume of endocrinology/nephrology clinical trial starts per sponsor, per reference molecule (top sponsors)
  • Figure 54: Volume of biosimilar endocrinology/nephrology clinical trial sites in the regulated markets and in ROW
  • Figure 55: Volume of biosimilar Phase III trials in A/I which have or do not have a switching component
  • Figure 56: Detailed outline of different types of switching designs used by sponsors in Phase III trials of A/I biosimilar products
  • Figure 57: Volume of clinical trials per switching design (A/I biosimilars)
  • Figure 58: Presence of switch elements in adalimumab biosimilar Phase III trials in regulated markets
  • Figure 59: Indications studied in adalimumab Phase III trials
  • Figure 60: Volume of switching trials per switch type, Phase III adalimumab biosimilar trials
  • Figure 61: Presence of switch elements in etanercept biosimilar Phase III trials in regulated markets
  • Figure 62: Indications studied in etanercept Phase III trials
  • Figure 63: Volume of switching trials per switch type, Phase III etanercept biosimilar trials
  • Figure 64: Presence of switch elements in infliximab biosimilar Phase III trials in regulated markets
  • Figure 65: Indications studied in infliximab Phase III trials
  • Figure 66: Volume of switching trials per switch type, Phase III infliximab biosimilar trials
  • Figure 67: Presence of switch elements in rituximab biosimilar Phase III trials in regulated markets
  • Figure 68: Indications studied in rituximab Phase III trials
  • Figure 69: Volume of switching trials per switch type, Phase III rituximab biosimilar trials

LIST OF TABLES

  • Table 1: Comparison of biosimilar approval pathways
  • Table 2: Indications in which Remicade and infliximab biosimilars have obtained approval in from the regulatory authorities in EU, US and Canada
  • Table 3: Indications in which Enbrel and etanercept biosimilars have obtained approval in from the regulatory authorities in EU, US and Canada
  • Table 4: Indications in which Rituxan/MabThera and rituximab biosimilars have obtained approval in from the regulatory authorities in EU, US and Canada
  • Table 5: Overview of FDA interchangeability guidelines
  • Table 6: Waves of biosimilar development
  • Table 7: Number of Phase I trials conducted by sponsors in the regulated regions, per indication studied
  • Table 8: Number of Phase III trials conducted by sponsors in the regulated regions, per indication studied
  • Table 9: Number of Phase I trials conducted by sponsors in the regulated regions, per indication studied
  • Table 10: Phase III trials of biosimilar trastuzumab in metastatic or early HER2-positive breast cancer patients
  • Table 11: Competitive landscape of biosimilar ranibizumab, 2011-17
  • Table 12: Competitive landscape of biosimilar follitropin alfa, 2011-17
  • Table 13: Competitive landscape of clinical-stage biosimilars in hematology, 2011-17
  • Table 14: Competitive landscape of clinical-stage biosimilars of peginterferon alfa for the treatment of hepatitis, 2011-17
  • Table 15: Competitive landscape of clinical-stage biosimilars in multiple sclerosis, 2011-17
  • Table 16: Adalimumab biosimilar Phase III trials in regulated markets: trial design
  • Table 17: Etanercept biosimilar Phase III trials in regulated markets: trial design
  • Table 18: Infliximab biosimilar Phase III trials in regulated markets: trial design
  • Table 19: Rituximab biosimilar Phase III trials in regulated markets: trial design
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