【レポートの概要(一部)】
1. Introduction to Cancer Biosimilars
2. Mechanism of Cancer Biosimilars
3. Considerations While Marketing Cancer Biosimilars in Global Market
4. EU & US Regulatory Considerations on Cancer Biosimilars
5. Global Cancer Biosimilars Market Overview
5.1 Current Market Scenario
5.2 Cancer Biosimilars Pipeline Overview
6. Global Cancer Biosimilars Market Dynamics
6.1 Favorable Market Parameters
6.2 Commercialization Challenges
7. Global Cancer Biosimilars Market Future Prospects
8. EMA Guidelines on Development & Marketing of Biosimilars
8.1 Development of Similar Biological Medicinal Products Containing r-hFSH
8.2 Similar Biological Medicinal Products Containing Interferon Beta
8.3 Immunogenicity Assessment of Monoclonal Antibodies Intended For In Vivo Clinical Use
8.4 Similar Biological Medicinal Products Containing Monoclonal Antibodies
8.5 Similar Biological Medicinal Products Containing Recombinant Erythropoietins
8.6 Similar Medicinal Products Containing Recombinant Human Soluble Insulin
8.7 Similar Medicinal Products Containing Somatropin
8.8 Similar Biological Medicinal Products Containing Biotechnology Derived Proteins as Active Substance
8.9 Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
8.10 Comparability of Biotechnology-Derived Medicinal Products After A Change In The Manufacturing Process
9. FDA Guidelines on Development & Marketing of Biosimilars
9.1 Quality Considerations In Demonstrating Biosimilarity To A Reference Protein Product
9.2 Scientific Considerations In Demonstrating Biosimilarity To A Reference Product
10. Regulatory Pathways for Development & Marketing of Biosimilars by Country
10.1 Australia
10.2 Canada
10.3 Japan
10.4 India
10.5 Malaysia
10.6 Saudi Arabia
10.7 Singapore
10.8 South Africa
10.9 South Korea
10.10 Turkey
11. Cancer Biosimilars Clinical Pipeline by Company, Indication & Phase
11.1 Unknown
11.2 Research
11.3 Preclinical
11.4 Clinical
11.5 Phase-I
11.6 Phase-I/II
11.7 Phase-II
11.8 Phase-III
11.9 Registered
12. Marketed Cancer Biosimilars Clinical Insight
12.1 Interferon alpha-2a Biosimilar (Inferon™/Inmutag™)
12.2 Interferon alpha-2b Biosimilar(Bioferon™)
12.3 Interferon alpha-2b Biosimilar(Intalfa®)
12.4 Interferon alpha-2b Biosimilar (Laboratorios Varifarma)
12.5 Interferon alpha-2b Biosimilar(ReliFeron®)
12.6 Interleukin-2 Biosimilar(Ilcass)
12.7 Peginterferon alfa-2b (Cylatron®)
12.8 Rituximab Biosimilar(Zytux™)
12.9 Rituximab Biosimilar(Acellbia™)
12.10 Rituximab Biosimilar(Reditux™/Tidecron®)
12.11 Rituximab Biosimilar(Mabtas)
12.12 Rituximab Biosimilar(MabThera®)
12.13 Trastuzumab (Herceptin®)
12.14 Trastuzumab Biosimilar(CANMAb™)
12.15 Filgrastim (Zarxio™)
13. Suspended & Discontinued Cancer Biosimilar Clinical Pipeline
13.1 No Development Reported
13.2 Discontinued
13.3 Suspended
14. Competitive Landscape
14.1 Actavis
14.2 Aequus BioPharma
14.3 Amega Biotech
14.4 Amgen
14.5 API Co. Ltd
14.6 AvesthaGen
14.7 AXXO
14.8 Bio Sidus
14.9 Biocad
14.10 Biocon
14.11 Biogenomics
14.12 BioSavita
14.13 BioXpress Therapeutics
14.14 Boehringer Ingelheim
14.15 Celltrion
14.16 CTI BioPharma
14.17 Dong-A Pharmaceutical
14.18 EPIRUS Biopharmaceuticals
14.19 Fujifilm Kyowa Kirin Biologics
14.20 Gedeon Richter
14.21 Glycotope
14.22 Green Cross
14.23 Harvest Moon Pharmaceuticals
14.24 IBioInc
14.25 Inbiopro Solutions
14.26 Ipca Laboratories
14.27 Lupin
14.28 MAbxience
14.29 Momenta Pharmaceuticals
14.30 Nanogen Biopharmaceutical
14.31 Oncobiologics
14.32 Pfizer
14.33 PharmaPraxis
14.34 PlantForm Corporation
14.35 Reliance Life Sciences
14.36 Samsung Bioepis
14.37 Teva Pharmaceutical
14.38 UMN Pharma
14.39 XBiotech
14.40 Yakult Honsha
14.41 Zydus Cadila
【レポート販売概要】
■ タイトル:癌治療用バイオシミラーの世界市場機会■ 英文:Global Cancer Biosimilars Market Opportunity Outlook
■ 発行日:2015年6月
■ 調査会社:KuicK Research
■ 商品コード:KUIK507141
■ 調査対象地域:グローバル
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