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Bevacizumab、生物相似藥:全球市場的洞察 (2020年)

Bevacizumab - Biosimilars Insight, 2020

出版商 DelveInsight Business Research LLP 商品編碼 955875
出版日期 按訂單生產 內容資訊 英文 125 Pages
商品交期: 10個工作天內
Bevacizumab、生物相似藥:全球市場的洞察 (2020年) Bevacizumab - Biosimilars Insight, 2020
出版日期: 按訂單生產內容資訊: 英文 125 Pages

本報告提供全球各國Bevacizumab的生物相似藥的疫情趨勢與今後預測相關分析,市場基本結構和最新形勢,整體臨床實驗的進展 (各階段的產品數等),主要的已上市/開發中產品 (40種以上)的特徵和臨床實驗情形,主要企業 (40公司以上)的簡介的主力商品,主要的治療藥的評估 (各產品種類、各臨床實驗階段、各給藥途徑、各分子類型)等資訊彙整,為您概述為以下內容。


第1章 主要洞察

第2章 Bevacizumab的生物相似藥:概述

第3章 摘要整理

  • 概要
  • 生技藥品的基礎
  • 生物相似藥與學名藥不同
  • 生物相似藥的經濟性:承諾低價格,但代價是什麼?
  • 關於生物相似藥患者應該預先知道之事

第4章 生物相似藥法規的展望

  • 北美
    • 美國
    • 加拿大
  • 歐洲
  • 亞太地區
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲
  • 其他的國家 (RoW)
    • 巴西
    • 墨西哥
    • 阿根廷
    • 沙烏地阿拉伯

第5章 Bevacizumab (參考產品:Avastin)

  • 藥物簡介
  • 產品概要
  • 法規核准、上市
  • 適應症
  • 作用機制
  • 投藥和管理
  • 劑量和含量
  • 劑量的調整
  • 合成途徑
  • 藥理學
  • 藥效學
  • 藥物動力學
  • 有害反應
  • 產品的概述
  • 開發里程碑

第6章 研究開發 (R&D)

  • 臨床實驗資訊
  • 安全性和有效性

第7章 Avastin的生物相似藥:新機會

第8章 Bevacizumab、生物相似藥的評估

  • 各產品種類的評估
  • 各給藥途徑的評估
  • 各分子類型的評估
  • 銷售量的評估

第9章 Bevacizumab、生物相似藥的簡介:各企業

  • Pfizer
  • Amgen
  • Celltrion
  • Prestige Biopharma

第10章 Bevacizumab、生物相似藥:競爭情形比較,各企業

第11章 Bevacizumab、生物相似藥: 競爭情形

  • 概況
  • 市場佔有率分析
  • 競爭模式

第12章 推動市場要素

第13章 阻礙市場要素

第14章 SWOT分析

第15章 附錄

第16章 參考文件

第17章 DelveInsight的服務內容

第18章 免責聲明

第19章 關於DelveInsight

Product Code: DIBI000003

DelveInsight's , "Bevacizumab- Biosimilar Insight, 2020," report provides comprehensive insights about 40+ companies and 40+ marketed and pipeline drugs in Bevacizumab Biosimilars landscape. It covers the marketed and pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

  • Global coverage

Bevacizumab Understanding

Bevacizumab: Overview

Bevacizumab, sold under the brand name Avastin, is a medication used to treat a number of types of cancers and a specific eye disease. There is a great deal of evidence indicating that vascular endothelial growth factor (VEGF) is important for the survival and proliferation of cancer cells. VEGF plays an important role in angiogenesis, lymphangiogenesis, and tumor growth, which are all factors that contribute to its attractiveness as a therapeutic target for anti-cancer therapies. In 2004, bevacizumab (Avastin) gained FDA approval for specific types of cancer, and became the first antiangiogenic agent introduced to the market. It is a humanized monoclonal IgG antibody, and inhibits angiogenesis by binding and neutralizing VEGF-A. Bevacizumab is generally indicated for use in combination with different chemotherapy regimens which are specific to the type, severity, and stage of cancer.

Bevacizumab Biosimilars: Drugs Chapters

This segment of the Bevacizumab report encloses its detailed analysis of various drugs in different stages of clinical development, including marketed, phase III, II, I and preclinical. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Bevacizumab Biosimilars: Marketed Drugs

  • Mvasi: Amgen

Mvasi is a vascular endothelial growth factor inhibitor. The U.S. Food and Drug Administration today approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.

  • Bryxta: Zydus

Bryxta is a recombinant humanized monoclonal antibody (containing 1337 amino acids) produced in Chinese Hamster Ovary cell line. VEGF is a signal protein which stimulates vasculogenesis and angiogenesis. Bevacizumab binds to VEGF and inhibits its interactions with VEGF receptors (VEGFRs), Flt-1 (VEGFR-1) and KDR (VEGFR-2), on the surface of endothelial cells. This results in regression of tumour vasculature and inhibition of new tumour vessel growth.

Further product details are provided in the report.

Bevacizumab Biosimilars: Emerging Drugs

  • HD204: Prestige BioPharma

Prestige BioPharma is developing HD204 for the treatment of several Solid Tumors. In 2019, Prestige BioPharma announced positive results from a phase I clinical trial (SAMSON-I) evaluating the pharmacokinetics (PK), safety and immunogenicity of biosimilar candidate HD204 to Avastin (bevacizumab).

  • GB 222: Genor Biopharma

Genor Biopharma is developing GB 222 for the treatment of Non-small cell lung cancer. The drug is currently in phase III stage f development.

Further product details are provided in the report.

Bevacizumab: Therapeutic Assessment

This segment of the report provides insights about the different Bevacizumab biosimilars segregated based on following parameters that define the scope of the report, such as:

  • Major Players in Bevacizumab

There are approx. 40+ key companies which are developing the therapies for Bevacizumab.

  • Phases

DelveInsight's report covers around 40+ products under different phases of clinical development like

  • Marketed stage products
  • Late stage products (BLA Filed and Phase III)
  • Mid-stage products (Phase II and
  • Early-stage products (Phase I) along with the details of
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates
  • Route of Administration

Bevacizumab pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Subcutaneous
  • Intravenous
  • Parenteral
  • Molecule Type

Products have been categorized under various Molecule types such as

  • Monoclonal antibodies
  • Peptide
  • Protein
  • Small molecule
  • Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Bevacizumab: Pipeline Development Activities

The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Bevacizumab biosimilars drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Bevacizumab biosimilar drugs.

Report Highlights:

  • The companies and academics are working to assess challenges and seek opportunities that could influence Bevacizumab R&D. The therapies under development are focused on novel approaches to treat/improve Bevacizumab.
  • In August 2020, Bio-Thera Solutions and BeiGene announced that the companies have executed a license, distribution, and supply agreement for China for Bio-Thera's BAT1706, an investigational biosimilar to Avastin (bevacizumab).
  • In July 2019, Amgen and Allergan announced that MVASI (bevacizumab-awwb), a biosimilar to Avastin (bevacizumab), and KANJINTITM (trastuzumab-anns), a biosimilar to Herceptin (trastuzumab), are now available in the United States (U.S.).
  • In June 2020, Samsung Bioepis announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AYBINTIO, a biosimilar candidate referencing Avastin (bevacizumab).
  • In March 2020, the FDA has accepted a Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to bevacizumab (Avastin), according to a press release from co-developers Biocon and Mylan. The BLA is seeking approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

Bevacizumab Biosimilars Report Insights

  • Bevacizumab Biosimilar Pipeline Analysis
  • Therapeutic Assessment
  • Sales Assessment
  • Unmet Needs
  • Impact of Drugs

Bevacizumab Biosimilar Report Assessment

  • Marketed Product profiles
  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Sales Assessment
  • Inactive drugs assessment
  • Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

  • How many companies are developing Bevacizumab Biosimilars?
  • How many Bevacizumab biosimilars are developed by each company?
  • How many emerging biosimilars are in mid-stage, and late-stage?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Bevacizumab biosimilars therapeutics?
  • What are the clinical studies going on for Bevacizumab biosimilars and their status?
  • What are the key designations that have been granted to the emerging drugs?

Key Players

  • BioIntegrator
  • Mycenax Biotech
  • Biocad
  • Daiichi Sankyo/ Amgen
  • Kashiv BioSciences
  • Harvest Moon Pharmaceuticals
  • Coherus BioSciences
  • Celltrion
  • Centus Biotherapeutics Limited
  • Shanghai Henlius Biotech
  • Innovent Biologics
  • mAbxience S.A
  • Amgen/ Allergan
  • Outlook Therapeutics
  • Pfizer
  • R-Pharm
  • Samsung Bioepis
  • Zhejiang Teruisi Pharmaceutical
  • Tanvex Biopharma
  • Pfizer
  • Zydus Cadila
  • Reliance Life Sciences
  • Laboratorio Elea
  • Biocon/Mylan
  • Bio-Thera Solutions
  • BioXpress Therapeutics
  • Boehringer Ingelheim
  • Zydus Cadila
  • Dr Reddy's
  • mAbxience
  • Genor Biopharma
  • Gene Techno Science

Key Products

  • BI-MAB-02
  • AiNEX
  • BCD-021
  • CHS-5217
  • CT-16
  • CT-P16
  • FKB238
  • HLX04
  • IBI-305
  • MB02
  • Mvasi
  • ONS-1045
  • PF-06439535 (ZIRABEV)
  • RPH001
  • SB8
  • SB9
  • TRS003
  • TX-16
  • Zirabev
  • Bryxta
  • BevaciRel
  • Lumiere
  • BAT1706
  • BX 2314
  • BI 695502
  • Bryxta
  • Versavo
  • Bevax
  • GB 222
  • GBS-004

Table of Contents

1. Key Insights

2. Bevacizumab Biosimilars: Snapshot

3. Executive Summary

  • 3.1. Overview
  • 3.2. The Basics of Biologics.
  • 3.3. Biosimilars are not the Same as Generic Drugs
  • 3.4. Economics of Biosimilars - the Promise of Lower Prices, but at What Cost?
  • 3.5. What Patients Need to Know About Biosimilars

4. Regulatory Outlook For Biosimilars

  • 4.1. North America
    • 4.1.1. US
    • 4.1.2. Canada
  • 4.2. Europe
  • 4.3. Asia Pacific
    • 4.3.1. China
    • 4.3.2. India
    • 4.3.3. Japan
    • 4.3.4. South Korea
    • 4.3.5. Australia
  • 4.4. Rest Of The World
    • 4.4.1. Brazil
    • 4.4.2. Mexico
    • 4.4.3. Argentina
    • 4.4.4. Saudi Arabia

More Countries would be added in the final report

5. Bevacizumab (Reference Product: Avastin)

  • 5.1. Drug Profile
  • 5.2. Product Overview
  • 5.3. Regulatory Approvals and Launch
  • 5.4. Indications
  • 5.5. Mechanism of Action
  • 5.6. Dosage and Administration
  • 5.7. Dosage and Strengths
  • 5.8. Dose Modification
  • 5.9. Route of Synthesis
  • 5.10. Pharmacology
  • 5.11. Pharmacodynamics
  • 5.12. Pharmacokinetics
  • 5.13. Adverse Reactions
  • 5.14. Product Snapshot
  • 5.15. Development Milestones

6. Research and Development

  • 6.1. Clinical Trials Information
  • 6.2. Safety and Efficacy

7. Avastin Biosimilar: Emerging Opportunities

8. Bevacizumab: Biosimilars Assessment

  • 8.1. Assessment by Product Type
  • 8.2. Assessment by Route of Administration
  • 8.3. Assessment by Molecule type
  • 8.4. Sales Assessment

9. Bevacizumab Biosimilars Profiles: By Company

    • 9.1.1. Pfizer
      • PF-06439535: Pfizer
      • Product Information
      • Research and Development
      • Other Development Activities
      • General Description Table
    • 9.1.2. Amgen
      • Mvasi: Amgen
      • Product Information
      • Research and Development
      • Other Development Activities
      • General Description Table
    • 9.1.3. Celltrion
      • CT-P16 : Celltrion
      • Product Information
      • Research and Development
      • Other Development Activities
      • General Description Table
    • 9.1.4. Prestige Biopharma
      • HD204 : Prestige Biopharma
      • Product Information
      • Research and Development
      • Other Development Activities
      • General Description Table

More Companies and products would be added in the final report

10. Bevacizumab Biosimilars: Comparative Landscape: By Company

11. Bevacizumab Biosimilars: Competitive Landscape

    • 11.1.1. Overview
    • 11.1.2. Market Share Analysis
    • 11.1.3. Competitive Scenario
      • Product Launches and approval
      • Partnerships, Collaborations and Agreements
      • Acquisitions
      • Expansions
      • Patent Expiration of Biologics

More information would be added in the final report

12. Market Drivers

13. Market Barriers

14. SWOT Analysis

15. Appendix

  • 15.1. Research Methodology
    • 15.1.1. Coverage
    • 15.1.2. Secondary Research

16. Bibliography

17. DelveInsight Capabilities

18. Disclaimer

19. About DelveInsight

List of Tables

  • Table 1 Total Products for Bevacizumab
  • Table 2 Late Stage Products
  • Table 3 Mid Stage Products
  • Table 4 Early Stage Products
  • Table 5 Pre-clinical & Discovery Stage Products
  • Table 6 Assessment by Product Type
  • Table 7 Assessment by Stage and Product Type
  • Table 8 Assessment by Route of Administration
  • Table 9 Assessment by Stage and Route of Administration
  • Table 10 Assessment by Molecule Type
  • Table 11 Assessment by Stage and Molecule Type
  • Table 12 Inactive Products

List of Figures

  • Figure 1 Total Products for Bevacizumab
  • Figure 2 Late Stage Products
  • Figure 3 Mid Stage Products
  • Figure 4 Early Stage Products
  • Figure 5 Preclinical and Discovery Stage Products
  • Figure 6 Assessment by Product Type
  • Figure 7 Assessment by Stage and Product Type
  • Figure 8 Assessment by Route of Administration
  • Figure 9 Assessment by Stage and Route of Administration
  • Figure 10 Assessment by Molecule Type
  • Figure 11 Assessment by Stage and Molecule Type
  • Figure 12 Inactive Products