市場調查報告書

Ranibizumab:生物相似藥的考察 (2020年)

Ranibizumab - Biosimilars Insight, 2020

出版商 DelveInsight Business Research LLP 商品編碼 955877
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
Ranibizumab:生物相似藥的考察 (2020年) Ranibizumab - Biosimilars Insight, 2020
出版日期: 2020年08月01日內容資訊: 英文 90 Pages
簡介

本報告含括Ranibizumab的生物相似藥,提供已上市及開發平台醫藥品相關全面的考察,各地區、國家法規環境,產品類型,階段,給藥途徑,各分子類型的治療藥的評估,市場成長的影響要素等分析。

目錄

第1章 主要考察

第2章 Ranibizumab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預先知道之事

第4章 生物相似藥的法規展望

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

第5章 Ranibizumab(參照產品:Lucentis)

  • 藥物簡介
  • 產品概要
  • 法規核准與發售
  • 適應症
  • 作用機制
  • 投藥和管理
  • 劑量和優勢
  • 劑量的變更
  • 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

  • 臨床試驗資訊
  • 安全性和有效性

第7章 Lucentis的生物相似藥:新機會

第8章 Ranibizumab: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
  • 銷售額評估

第9章 Ranibizumab的生物相似藥的簡介:各企業

    • Xbrane
    • Samsung Bioepis
    • Intas Biopharmaceuticals
    • Coherus

第10章 Ranibizumab的生物相似藥:比較形勢:各企業

第11章 Ranibizumab的生物相似藥: 競爭情形

    • 概要
    • 市場佔有率分析
    • 競爭模式

第12章 促進市場成長因素

第13章 阻礙市場成長要素

第14章 SWOT分析

第15章 附錄

  • 調查手法
    • 調查範圍
    • 2次調查

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: DIBI000005

DelveInsight's , "Ranibizumab- Biosimilar Insight, 2020," report provides comprehensive insights about 20+ companies and 20+ marketed and pipeline drugs in Ranibizumab 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

Ranibizumab Understanding

Ranibizumab: Overview

Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that has been approved to treat the "wet" type of age-related macular degeneration, a common form of age-related vision loss. Its effectiveness is similar to that of bevacizumab. Ranibizumab was developed by Genentech and marketed by them in the United States, and elsewhere by Novartis, under the brand name Lucentis. It is often used for age-related wet macular degeneration. Its effectiveness is similar to that of bevacizumab and aflibercept.

Ranibizumab Biosimilars: Drugs Chapters

This segment of the Ranibizumab 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.

Ranibizumab Biosimilars: Marketed Drugs

  • Razumab: Intas Pharmaceuticals

Razumab is the tenth biosimilar launched by Intas in India, by far the largest number of indigenously developed biosimilars by any company. Since 2004, when Intas launched its first biosimilar, Intas has constantly worked to bring the latest in biological therapies to Indian patients at affordable prices. With its robust pipeline of future products under development, Intas aims to continue on this endeavor. Till date, Intas is also the only company from India to have launched a biosimilar in the highly regulated European market and is also the only company from India to have two of its biosimilars filed for registration in the US. Its first biosimilar for global markets, Accofil (filgratsim) was launched in Europe earlier this year. The company expects to launch its first biosimilar in the US within the next 9 - 12 months. Intas' manufacturing facilities are approved by global regulatory agencies such as EMA, ANVISA, WHO and others. Razumab is also manufactured in the same facilities as its other biosimilars.

Further product details are provided in the report.

Ranibizumab Biosimilars: Emerging Drugs

  • SB-11: Samsung Bioepis

SB11 is a ranibizumab biosimilar candidate, to reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD). The drug is currently in phase III stage of development.

Further product details are provided in the report.

Ranibizumab: Therapeutic Assessment

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

  • Major Players in Ranibizumab

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

  • 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

Ranibizumab 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
  • 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.

Ranibizumab: Pipeline Development Activities

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

Report Highlights:

  • The companies and academics are working to assess challenges and seek opportunities that could influence Ranibizumab R&D. The therapies under development are focused on novel approaches to treat/improve Ranibizumab.
  • In May 2020, Samsung Bioepis announced that the primary endpoints have been met in the randomized, double-masked, phase 3 trial comparing the efficacy, safety and immunogenicity of SB11, a ranibizumab biosimilar candidate, to reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD).
  • In November 2019, Coherus BioSciences announced the Company has acquired exclusive rights from Bioeq to commercialize Bioeq's biosimilar candidate to Lucentis (ranibizumab) in the United States. Bioeq plans to file a Biologics License Application with the U.S. Food and Drug Administration in the fourth quarter of 2019 and Coherus plans to launch the product in 2021.
  • In April 2020, Xbrane Biopharma reports that, despite the difficulties posed by the Covid-19 pandemic, it will continue to recruit patients for the ongoing Phase III trial of its Xlucane (ranibizumab) biosimilar product, and that it is still on track towards regulatory approval ahead of Lucentis patent expiration in the EU.

Ranibizumab Biosimilars Report Insights

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

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

Key Players

  • Xbrane
  • Senju Pharmaceutical
  • Samsung Bioepis
  • Polus BioPharm
  • PlantForm Corporation
  • Pfenex
  • Lupin
  • Intas Biopharmaceuticals
  • Ildong Pharmaceutical
  • Harvest Moon Pharmaceuticals
  • Gene Techno Science
  • Coherus
  • Chong Kun Dang
  • Biocure Technology
  • BIOCND
  • Qilu Pharmaceuticals
  • Bioeq
  • Formycon

Key Products

  • Xlucane
  • SJP 0133
  • SB-11
  • PDP807
  • PF582
  • Razumab
  • IDB-0062
  • GBS-007
  • CHS-3351
  • CKD-701
  • BCD 300
  • FYB201

Table of Contents

1. Key Insights

2. Ranibizumab 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. Ranibizumab (Reference Product: Lucentis)

  • 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. Lucentis Biosimilar: Emerging Opportunities

8. Ranibizumab: 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. Ranibizumab Biosimilars Profiles: By Company

    • 9.1.1. Xbrane
      • 9.1.1.1. Xlucane: Xbrane
      • 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. SB-11: 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. Intas Biopharmaceuticals
      • 9.1.3.1. Razumab: Intas Biopharmaceuticals
      • 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. Coherus
      • 9.1.4.1. CHS-3351: Coherus
      • 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

More Companies and products would be added in the final report

10. Ranibizumab Biosimilars: Comparative Landscape: By Company

11. Ranibizumab 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 Ranibizumab
  • 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 Ranibizumab
  • 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