市場調查報告書

Infliximab - 生物相似藥考察:2020年

Infliximab - Biosimilars Insight, 2020

出版商 DelveInsight Business Research LLP 商品編碼 955878
出版日期 內容資訊 英文 90 Pages
商品交期: 最快1-2個工作天內
價格
Infliximab - 生物相似藥考察:2020年 Infliximab - Biosimilars Insight, 2020
出版日期: 2020年08月01日內容資訊: 英文 90 Pages
簡介

本報告提供Infliximab 生物相似藥形勢調查分析,以35個以上的企業,45個以上的上市藥、開發平台藥物為對象,醫藥品簡介,評估等相關的系統性資訊。

目錄

第1章 主要考察

第2章 Infliximab 生物相似藥:概述

第3章 摘要整理

第4章 生物相似藥的法規預測

  • 北美
    • 美國
    • 加拿大
  • 歐洲
  • 亞太地區
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲
  • 其他地區
    • 巴西
    • 墨西哥
    • 阿根廷
    • 沙烏地阿拉伯

第5章 Infliximab (商品名:Remicade)

  • 醫藥品簡介
  • 產品概要
  • 法規核准與發售
  • 適應症
  • 作用機制
  • 用量與管理
  • 用量和優勢
  • 劑量變更
  • 合成途徑
  • 藥理學
  • 藥效學
  • 藥物動力學
  • 有害反應
  • 產品概述
  • 開發里程碑

第6章 研究開發

  • 臨床試驗資訊
  • 安全性和有效性

第7章 Remicade生物相似藥:新興機會

第8章 Infliximab :生物相似藥的評估

  • 評估:各產品類型
  • 評估:各給藥途徑
  • 評估:各分子類型
  • 銷售評估

第9章 Infliximab 生物相似藥簡介:各企業

  • Pfizer
  • Samsung Bioepis
  • Celltrion
  • Nichiiko Pharmaceutical
  • Sandoz

第10章 Infliximab 生物相似藥比較形勢:各企業

第11章 Infliximab 生物相似藥:競爭情形

  • 概要
  • 市場佔有率分析
  • 競爭模式

第12章 推動市場要素

第13章 市場障礙

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

目錄
Product Code: DIBI000006

DelveInsight's , "Infliximab- Biosimilar Insight, 2020," report provides comprehensive insights about 35+ companies and 45+ marketed and pipeline drugs in Infliximab 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

Infliximab Understanding

Infliximab: Overview

Infliximab, a chimeric monoclonal antibody, sold under the brand name Remicade among others, is a medication used to treat a number of autoimmune diseases. This includes Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, and Behcet's disease. Infliximab is produced by a recombinant cell line cultured by continuous perfusion. Tumor necrosis factor-alpha (TNF-α) is a key proinflammatory cytokine involved in chronic inflammatory diseases. Its hyperactivity and enhanced signalling pathways can be observed in inflammatory diseases where it activates further pro-inflammatory cascades. By binding to both the soluble subunit and the membrane-bound precursor of TNF-α 1, infliximab disrupts the interaction of TNF-α with its receptors and may also cause lysis of cells that produce TNF-α 1

Infliximab Biosimilars: Drugs Chapters

This segment of the Infliximab 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.

Infliximab Biosimilars: Marketed Drugs

  • Inflectra: Celltrion/Pfizer

Inflectra will be the first biosimilar monoclonal antibody (mAb) and only the second biosimilar to be available in the U.S. It is approved for the treatment of:adult patients and pediatric patients (ages six years and older) with moderate to severely active Crohn's disease who have had an inadequate response to conventional therapy;adult patients with moderate to severely active ulcerative colitis who have had an inadequate response to conventional therapy; andmmoderate to severely active rheumatoid arthritis in combination with methotrexate; active ankylosing spondylitis; active psoriatic arthritis; and chronic severe plaque psoriasis.

  • Renflexis: Merck

Renflexis is a prescription medicine that treats the following autoimmune diseases:

Crohn's Disease (moderately to severely active): Can reduce signs and symptoms and induce and maintain remission in adult patients with moderately to severely active Crohn's disease who haven't responded well to other therapies

Pediatric Crohn's Disease (moderately to severely active): Can reduce signs and symptoms and induce and maintain remission in children (ages 6-17) with moderately to severely active Crohn's disease who haven't responded well to other therapies

Ulcerative Colitis (moderately to severely active): Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in adult patients with moderately to severely active ulcerative colitis who haven't responded well to other therapies

Pediatric Ulcerative Colitis (moderately to severely active): Can reduce signs and symptoms, induce and maintain remission, promote intestinal healing, and reduce or stop the need for steroids in children (ages 6-17) with moderately to severely active ulcerative colitis who haven't responded well to other therapies

Further product details are provided in the report.

Infliximab Biosimilars: Emerging Drugs

  • BCD 055: Biocad

A biosimilar of infliximab, designated as BCD 055, is being developed by Biocad for the treatment of ankylosing spondylitis and rheumatoid arthritis.

  • CT-P17: Celltrion

Genor Biopharma (a subsidiary of Walvax Biotechnology) is developing a biosimilar of infliximab, designated as GB 242, for the treatment of Autoimmune disorders; Rheumatoid arthritis. The drug is currently in phase III stage of development.

Further product details are provided in the report.

Infliximab: Therapeutic Assessment

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

  • Major Players in Infliximab

There are approx. 20+ key companies which are developing the therapies for Infliximab.

  • Phases

DelveInsight's report covers around 20+ 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

Infliximab 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.

Infliximab: Pipeline Development Activities

The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Infliximab 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 Infliximab biosimilar drugs.

Report Highlights:

  • The companies and academics are working to assess challenges and seek opportunities that could influence Infliximab R&D. The therapies under development are focused on novel approaches to treat/improve Infliximab.
  • In July 2017, Merck had launched in the U.S. a biosimilar of Remicade (infliximab), the blockbuster immune-mediated inflammatory disorders treatment it markets outside the U.S., including Europe, while partner Janssen Biotech markets the drug stateside.
  • In December 2017, Pfizer announced that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade (infliximab) for all eligible indications of the reference product. The FDA has approved IXIFI as a treatment for patients with rheumatoid arthritis, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

Infliximab Biosimilars Report Insights

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

Infliximab 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 Infliximab Biosimilars?
  • How many Infliximab 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 Infliximab biosimilars therapeutics?
  • What are the clinical studies going on for Infliximab biosimilars and their status?
  • What are the key designations that have been granted to the emerging drugs?

Key Players

  • Sandoz
  • Samsung Bioepis
  • Merck
  • Nichiiko Pharmaceutical
  • Aprogen
  • Nichi-Iko Pharmaceutical
  • MabPharm
  • Sorrento
  • LG Chem
  • Hospira
  • Harvest Moon Pharmaceuticals
  • Genor Biopharma
  • EPIRUS
  • Reliance Life Sciences
  • Curaxys
  • Pfizer
  • Celltrion
  • Biocad
  • Amgen

Key Products

  • Zessly
  • Renflexis/SB2
  • SB2
  • Infimab
  • Ixifi
  • GS 071
  • NI-071
  • CMAB008
  • STI-002
  • LBIM-0101
  • Inflectra
  • GB 242
  • BOW015
  • Inflectra
  • Remsima
  • BCD-055
  • Avsola

Table of Contents

1. Key Insights

2. Infliximab 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. Infliximab (Reference Product: Remicade)

  • 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. Remicade Biosimilar: Emerging Opportunities

8. Infliximab: 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. Infliximab Biosimilars Profiles: By Company

    • 9.1.1. Pfizer
      • 9.1.1.1. Ixifi: Pfizer
      • 9.1.1.1.1. Product Information
      • 9.1.1.1.2. Research and Development
      • 9.1.1.1.3. Other Development Activities
      • 9.1.1.1.4. General Description Table
    • 9.1.2. Samsung Bioepis
      • 9.1.2.1. SB2: Samsung Bioepis
      • 9.1.2.1.1. Product Information
      • 9.1.2.1.2. Research and Development
      • 9.1.2.1.3. Other Development Activities
      • 9.1.2.1.4. General Description Table
    • 9.1.3. Celltrion
      • 9.1.3.1. CT-P17: Celltrion
      • 9.1.3.1.1. Product Information
      • 9.1.3.1.2. Research and Development
      • 9.1.3.1.3. Other Development Activities
      • 9.1.3.1.4. General Description Table
    • 9.1.4. Nichiiko Pharmaceutical
      • 9.1.4.1. GS 071: Nichiiko Pharmaceutical
      • 9.1.4.1.1. Product Information
      • 9.1.4.1.2. Research and Development
      • 9.1.4.1.3. Other Development Activities
      • 9.1.4.1.4. General Description Table
    • 9.1.5. Sandoz
      • 9.1.5.1. Zessly: Sandoz
      • 9.1.5.1.1. Product Information
      • 9.1.5.1.2. Research and Development
      • 9.1.5.1.3. Other Development Activities
      • 9.1.5.1.4. General Description Table

More Companies and products would be added in the final report

10. Infliximab Biosimilars: Comparative Landscape: By Company

11. Infliximab Biosimilars: Competitive Landscape

    • 11.1.1. Overview
    • 11.1.2. Market Share Analysis
    • 11.1.3. Competitive Scenario
      • 11.1.3.1. Product Launches and approval
      • 11.1.3.2. Partnerships, Collaborations and Agreements
      • 11.1.3.3. Acquisitions
      • 11.1.3.4. Expansions
      • 11.1.3.5. 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 Infliximab
  • 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 Infliximab
  • 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