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ヒュミラ (アダリムマブ) バイオシミラーの治験分析

Humira Biosimilars Clinical Trial Insight

発行 PNS Pharma 商品コード 374504
出版日 ページ情報 英文 80 Pages
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ヒュミラ (アダリムマブ) バイオシミラーの治験分析 Humira Biosimilars Clinical Trial Insight
出版日: 2016年10月17日 ページ情報: 英文 80 Pages
概要

当レポートでは、臨床パイプラインにおけるヒュミラ薬の33のバイオシミラー (バイオ後続品) について検証し、臨床考察、開発タイムライン、特許分析、開発段階など、体系的な情報を提供しています。

第1章 ヒュミラ (アダリムマブ) の臨床考察

  • 臨床概要
  • 企業パートナシップ・契約
  • 特許分析:適応症別
  • オーファン状況:適応症・国別
  • 商標:国別/地域別

ヒュミラバイオシミラーの臨床考察:企業別

第2章 アダリムマブ バイオシミラー:AET BioTech/BioXpress Therapeutics

  • 臨床考察
  • 開発タイムライン
  • 開発段階

第3章 アダリムマブ バイオシミラー:Alphamab

第4章 アダリムマブ バイオシミラー:Alteogen/Cristalia

第5章 アダリムマブ バイオシミラー:Amgen

第6章 アダリムマブ バイオシミラー:Axxo

第7章 アダリムマブ バイオシミラー:Biocad

第8章 アダリムマブ バイオシミラー:BIOCND/Genor Biopharma

第9章 アダリムマブ バイオシミラー:Biocon/Mylan

第10章 アダリムマブ バイオシミラー:Bionovis/The Instituto Vital Brazil

第11章 アダリムマブ バイオシミラー:Boehringer Ingelheim

第12章 アダリムマブ バイオシミラー:Celltrion

第13章 アダリムマブ バイオシミラー:CinnaGen

第14章 アダリムマブ バイオシミラー:Coherus BioSciences

第15章 アダリムマブ バイオシミラー:Dong A ST/明治製菓ファルマ

第16章 アダリムマブ バイオシミラー:EMD Serono/Merck

第17章 アダリムマブ バイオシミラー:協和キリン富士フイルムバイオロジクス

第18章 アダリムマブ バイオシミラー:TGene Techno Science

第19章 アダリムマブ バイオシミラー:Harvest Moon Pharmaceuticals

第20章 アダリムマブ バイオシミラー:Hetero Drugs

第21章 アダリムマブ バイオシミラー:Innovent Biologics

第22章 アダリムマブ バイオシミラー:LG Life Sciences

第23章 アダリムマブ バイオシミラー:mAbxience

第24章 アダリムマブ バイオシミラー:Meridian Biopharmaceuticals

第25章 アダリムマブ バイオシミラー:Momenta Pharmaceuticals

第26章 アダリムマブ バイオシミラー:ncobiologics

第27章 アダリムマブ バイオシミラー:Pfizer

第28章 アダリムマブ バイオシミラー:PlantPraxis

第29章 アダリムマブ バイオシミラー:Reliance Life Sciences

第30章 アダリムマブ バイオシミラー:Samsung Bioepis

第31章 アダリムマブ バイオシミラー:Sandoz

第32章 アダリムマブ バイオシミラー:Shanghai Henlius Biotech

第33章 アダリムマブ バイオシミラー:Therapeutic Proteins International

第34章 アダリムマブ バイオシミラー:Zydus Cadila

第35章 ヒュミラ (アダリムマブ) バイオシミラーの開発に関連する特許訴訟の課題

  • Amgen v/s AbbVie
  • Coherus v/s AbbVie

図表リスト

目次

"Humira Biosimilars Clinical Trial Insight" report by PNS Pharma gives comprehensive clinical insight on 33 biosimilars version of Humira drug in clinical pipeline. More than 10 of these biosimilars are in Phase-III trials and are expected to be commercially available in next 5-8 years. The patent protection assigned to Humira will expire in 2016 for US and 2018 for European market.

The Humira stands for Human Monoclonal Antibody in Rheumatoid Arthritis. It is also termed as Adalimumab or D2E7 and is a recombinant Immunoglobulin G1 monoclonal antibody which is specific for tumor necrosis factor alpha (TNF-α). It is a drug designed by the mode of recombinant DNA technology for the treatment of rheumatoid arthritis, psoriatic arthritis, Crohn's disease and ulcerative colitis. In the rheumatoid arthritis adalimumab has the equivalent efficacy as that of methotrexate.

The chemical and biological components of Humira define it as a TNF inhibiting anti-inflammatory biologic medication. It binds to the TNF-α which leads to the inflammatory response of autoimmune diseases but after the conjugation of Humira it reduces the inflammatory response.

The mechanism of action includes the binding of HUMIRA specifically to TNF-α and renders it, incapable of binding to its receptors on cell surfaces. TNF-α exerts its pro-inflammatory role by binding to its cell surface receptor. When HUMIRA binds to the membrane bound version of TNF-α on TNF-α-producing cells, it can lead to lysis of these TNF-α producing cell in the presence of complement.

TNF- α level is found elevated in the synovial fluids of rheumatoid arthritis. TNF-α is one of the important factors that contribute to the pathology and perpetuation of the inflamed and destroyed joints in rheumatoid arthritis. Given that rheumatoid arthritis is a complex disease with multiple factors involved, the ability for a monoclonal antibody to neutralize the function of one single cytokine TNF-α and greatly improve the symptoms and progression of rheumatoid arthritis.

It is produced by Abbot Laboratories but originally Humira was emerged from collaboration between Bioresearch Center in Massachusetts (BASF) and the Cambridge Antibody Technologies in the UK. Mid stage clinical trials were so promising that, at the end of 2000, Abbott agreed to buy the BASF Bioresearch Center for US$ 6.9 Billion. When Humira was launched in 2003, it was the third TNF-alpha antibody to the market. Its US, FDA approval for marketing was achieved on December 31, 2002. In 2012 to 2015 Humira topped the top selling pharmaceutical product lists and in 2015, Humira had topped US$ 14 Billion of sales globally.

However, its superior dosing schedule and improved toleration over existing therapy enabled it to become the best in class agent. Furthermore, Abbott had a robust development program for Humira and expanded its use to other inflammatory disease such as psoriasis, Crohn's disease, and juvenile idiopathic arthritis. While prescribed to far fewer patients than Lipitor, the high cost of this biological medicine is such that Humira's sales were projected to exceed US$ 9 Billion.

In December 2014, Indian drug maker Cadila Healthcare declared the launch of the first adalimumab biosimilar at a fifth of its U.S. price. The generic has been launched under the brand name Exemptia. In January 2016, another Indian drug maker Torrent Pharmaceuticals launched its biosimilar for adalimumab. Torrent's Adfrar would be the second generic biosimilar of adalimumab in the world. In September 2016 the US FDA approved Amgens biosimilar adalimumab-atto sold under the brand name Amjevita.

Table of Contents

1. Humira (Adalimumab) Clinical Insight

  • 1.1 Clinical Introduction
  • 1.2 Company Partnerships & Agreements
  • 1.3 Patent Analysis by Indication
  • 1.4 Designated Orphan Status by Indication & Country
  • 1.5 Brand Names by Country/Region

Humira Biosimilars Clinical Insight by Company

2. Adalimumab Biosimilar - AET BioTech/BioXpress Therapeutics

  • 2.1 Clinical Insight
  • 2.2 Development Timeline
  • 2.3 Phase of Development

3. Adalimumab Biosimilar - Alphamab

  • 3.1 Clinical Insight
  • 3.2 Development Timeline
  • 3.3 Phase of Development

4. Adalimumab Biosimilar - Alteogen/Cristalia

  • 4.1 Clinical Insight
  • 4.2 Phase of Development

5. Adalimumab Biosimilar - Amgen

  • 5.1 Clinical Insight
  • 5.2 Development Timeline
  • 5.3 Phase of Development

6. Adalimumab Biosimilar - Axxo

  • 6.1 Clinical Insight
  • 6.2 Phase of Development

7. Adalimumab Biosimilar - Biocad

  • 7.1 Clinical Insight
  • 7.2 Development Timeline
  • 7.3 Phase of Development

8. Adalimumab Biosimilar - BIOCND/Genor Biopharma

  • 8.1 Clinical Insight
  • 8.2 Development Timeline
  • 8.3 Phase of Development

9. Adalimumab Biosimilar - Biocon/Mylan

  • 9.1 Clinical Insight
  • 9.2 Development Timeline
  • 9.3 Phase of Development

10. Adalimumab Biosimilar - Bionovis/The Instituto Vital Brazil

  • 10.1 Clinical Insight
  • 10.2 Development Timeline
  • 10.3 Phase of Development

11. Adalimumab Biosimilar - Boehringer Ingelheim

  • 11.1 Clinical Insight
  • 11.2 Development Timeline
  • 11.3 Phase of Development

12. Adalimumab Biosimilar - Celltrion

  • 12.1 Clinical Insight
  • 12.2 Phase of Development

13. Adalimumab Biosimilar - CinnaGen

  • 13.1 Clinical Insight
  • 13.2 Phase of Development

14. Adalimumab Biosimilar - Coherus BioSciences

  • 14.1 Clinical Insight
  • 14.2 Development Timeline
  • 14.3 Phase of Development

15. Adalimumab Biosimilar - Dong A ST/Meiji Seika Pharma

  • 15.1 Clinical Insight
  • 15.2 Development Timeline
  • 15.3 Phase of Development

16. Adalimumab Biosimilar - EMD Serono/Merck

  • 16.1 Clinical Insight
  • 16.2 Development Timeline
  • 16.3 Phase of Development

17. Adalimumab Biosimilar - Fujifilm Kyowa Kirin Biologics

  • 17.1 Clinical Insight
  • 17.2 Development Timeline
  • 17.3 Phase of Development

18. Adalimumab Biosimilar - Gene Techno Science

  • 18.1 Clinical Insight
  • 18.2 Phase of Development

19. Adalimumab Biosimilar - Harvest Moon Pharmaceuticals

  • 19.1 Clinical Insight
  • 19.2 Development Timeline
  • 19.3 Phase of Development

20. Adalimumab Biosimilar - Hetero Drugs

  • 20.1 Clinical Insight
  • 20.2 Development Timeline
  • 20.3 Phase of Development

21. Adalimumab Biosimilar - Innovent Biologics

  • 21.1 Clinical Insight
  • 21.2 Development Timeline
  • 21.3 Phase of Development

22. Adalimumab Biosimilar - LG Life Sciences

  • 22.1 Clinical Insight
  • 22.2 Development Timeline
  • 22.3 Phase of Development

23. Adalimumab Biosimilar - mAbxience

  • 23.1 Clinical Insight
  • 23.2 Development Timeline
  • 23.3 Phase of Development

24. Adalimumab Biosimilar - Meridian Biopharmaceuticals

  • 24.1 Clinical Insight
  • 24.2 Phase of Development

25. Adalimumab Biosimilar - Momenta Pharmaceuticals

  • 25.1 Clinical Insight
  • 25.2 Development Timeline
  • 25.3 Phase of Development

26. Adalimumab Biosimilar - Oncobiologics

  • 26.1 Clinical Insight
  • 26.2 Development Timeline
  • 26.3 Phase of Development

27. Adalimumab Biosimilar - Pfizer

  • 27.1 Clinical Insight
  • 27.2 Development Timeline
  • 27.3 Phase of Development

28. Adalimumab Biosimilar - PlantPraxis

  • 28.1 Clinical Insight
  • 28.2 Development Timeline
  • 28.3 Phase of Development

29. Adalimumab Biosimilar - Reliance Life Sciences

  • 29.1 Clinical Insight
  • 29.2 Development Timeline
  • 29.3 Phase of Development

30. Adalimumab Biosimilar - Samsung Bioepis

  • 30.1 Clinical Insight
  • 30.2 Development Timeline
  • 30.3 Phase of Development

31. Adalimumab Biosimilar - Sandoz

  • 31.1 Clinical Insight
  • 31.2 Development Timeline
  • 31.3 Phase of Development

32. Adalimumab Biosimilar - Shanghai Henlius Biotech

  • 32.1 Clinical Insight
  • 32.2 Development Timeline
  • 32.3 Phase of Development

33. Adalimumab Biosimilar - Therapeutic Proteins International

  • 33.1 Clinical Insight
  • 33.2 Phase of Development

34. Adalimumab Biosimilar - Zydus Cadila

  • 34.1 Clinical Insight
  • 34.2 Development Timeline
  • 34.3 Phase of Development

35. Patent Litigation Issues Involving Development of Humira (Adalimumab) Biosimilar

  • 35.1 Amgen v/s AbbVie
  • 35.2 Coherus v/s AbbVie

List of Tables

  • Table 1-1: Humira Clinical Trial by Phase of Development
  • Table 1-2: Humira - Designated Orphan Status by Indication & Country
  • Table 1-3: Humira - Brand Names by Country/Region
  • Table 2-1: AET BioTech/BioXpress Therapeutics Adalimumab Biosimilar by Indication & Phase
  • Table 3-1: Alphamab Adalimumab Biosimilar by Indication & Phase
  • Table 4-1: Alteogen/Cristalia Adalimumab Biosimilar by Indication & Phase
  • Table 5-1: Amgen Adalimumab Biosimilar by Indication & Phase
  • Table 6-1: Axxo Adalimumab Biosimilar by Indication & Phase
  • Table 7-1 Biocad Adalimumab Biosimilar by Indication & Phase
  • Table 8-1: BIOCND/Genor Biopharma Adalimumab Biosimilar by Indication & Phase
  • Table 9-1: Biocon/Mylan Adalimumab Biosimilar by Indication & Phase
  • Table 10-1: Bionovis/The Instituto Vital Brazil Adalimumab Biosimilar by Indication & Phase
  • Table 11-1: Boehringer Ingelheim Adalimumab Biosimilar by Indication & Phase
  • Table 12-1: Celltrion Adalimumab Biosimilar by Indication & Phase
  • Table 13-1: CinnaGen Adalimumab Biosimilar by Indication & Phase
  • Table 14-1: Coherus BioSciences Adalimumab Biosimilar by Indication & Phase
  • Table 15-1: Dong A ST/Meiji Seika Pharma Adalimumab Biosimilar by Indication & Phase
  • Table 16-1: EMD Serono/Merck Adalimumab Biosimilar by Indication & Phase
  • Table 17-1: Fujifilm Kyowa Kirin Biologics Adalimumab Biosimilar by Indication & Phase
  • Table 18-1: Gene Techno Science Adalimumab Biosimilar by Indication & Phase
  • Table 19-1: Harvest Moon Pharmaceuticals Adalimumab Biosimilar by Indication & Phase
  • Table 20-1: Hetero Drugs Adalimumab Biosimilar by Indication & Phase
  • Table 21-1: Innovent Biologics Adalimumab Biosimilar by Indication & Phase
  • Table 22-1: LG Life Sciences Adalimumab Biosimilar by Indication & Phase
  • Table 23-1: mAbxience Adalimumab Biosimilar by Indication & Phase
  • Table 24-1: Meridian Biopharmaceuticals Adalimumab Biosimilar by Indication & Phase
  • Table 25-1: Momenta Pharmaceuticals Adalimumab Biosimilar by Indication & Phase
  • Table 26-1: Oncobiologics Adalimumab Biosimilar by Indication & Phase
  • Table 27-1: Pfizer Adalimumab Biosimilar by Indication & Phase
  • Table 28-1: PlantPraxis Adalimumab Biosimilar by Indication & Phase
  • Table 29-1: Reliance Life Sciences Adalimumab Biosimilar by Indication & Phase
  • Table 30-1: Samsung Bioepis Adalimumab Biosimilar by Indication & Phase
  • Table 31-1: Sandoz Adalimumab Biosimilar by Indication & Phase
  • Table 32-1: Shanghai Henlius Biotech Adalimumab Biosimilar by Indication & Phase
  • Table 33-1: Therapeutic Proteins International Adalimumab Biosimilar by Indication & Phase
  • Table 34-1: Zydus Cadila Adalimumab Biosimilar by Indication & Phase
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