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Filgrastim、生物相似藥:全球市場的洞察 (2020年)

Filgrastim - Biosimilar Insight, 2020

出版商 DelveInsight Business Research LLP 商品編碼 955879
出版日期 按訂單生產 內容資訊 英文 70 Pages
商品交期: 10個工作天內
Filgrastim、生物相似藥:全球市場的洞察 (2020年) Filgrastim - Biosimilar Insight, 2020
出版日期: 按訂單生產內容資訊: 英文 70 Pages

本報告提供全球各國Filgrastim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 (20種以上)的特徵和臨床實驗情形,主要企業 (20家公司以上)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 Filgrastim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
  • 其他的國家 (RoW)
    • 巴西
    • 墨西哥
    • 阿根廷
    • 沙烏地阿拉伯

第5章 Filgrastim (參照產品:Neupogen)

  • 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 Neupogen的生物相似藥:新機會

第8章 Filgrastim、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 Filgrastim、生物相似藥的簡介:各企業

  • Pfizer
  • Novartis
  • Zydus Cadila
  • Bio-Ker
  • Sandoz

第10章 Filgrastim、生物相似藥:競爭情形比較,各企業

第11章 Filgrastim、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: DIBI000007

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

Filgrastim Understanding

Filgrastim: Overview

Filgrastim, sold under the brand name Neupogen among others, is a medication used to treat low neutrophil count. Low neutrophil counts may occur with HIV/AIDS, following chemotherapy or radiation poisoning, or be of an unknown cause. It is marketed as the brand name Neupogen by Amgen (initially approved in 1998). Filgrastim is a growth factor that stimulates the production, maturation, and activation of neutrophils (a type of white blood cell). Filgrastim also stimulates the release of neutrophils from the bone marrow. In patients receiving chemotherapy, filgrastim can accelerate the recovery of neutrophils, reducing the neutropenic phase (the time in which people are susceptible to infections).

Filgrastim Biosimilars: Drugs Chapters

This segment of the Filgrastim 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.

Filgrastim Biosimilars: Marketed Drugs

  • Nivestym: Pfizer

Nivestym is a leukocyte growth factor that primarily stimulates neutrophils. The G-CSF receptor through which Nivestym acts has also been found on tumor cell lines. The possibility that Nivestym acts as a growth factor for any tumor type cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established. Nivestym is used to treat neutropenia, a lack of certain white blood cells caused by cancer, bone marrow transplant, receiving chemotherapy, or by other conditions. Nivestym may also be used for purposes not listed in this medication guide. In July 2018, Pfizer announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NIVESTYM (filgrastim-aafi), a biosimilar to Neupogen1 (filgrastim), for all eligible indications of the reference product.

  • Grastofil: Apotex/Intas

Grastofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of Grastofil are similar in adults and children receiving cytotoxic chemotherapy. Grastofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs). The active substance in Grastofil, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF). Filgrastim acts in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.

Further product details are provided in the report.

Filgrastim Biosimilars: Emerging Drugs

  • TX-01: Tanvex Biopharma

Tanvex Biopharma is developing Filgrastim biosimilar labeled as TX-01 for the treatment of Neutropenia. The mechanism of action of the drug is that it acts as Haematopoietic cell growth factor stimulants. In 2019, Tanvex BioPharma receives complete response letter from the US FDA for filgrastim biosimilar (TX 01) in Neutropenia.

  • GranNEX: Mycenax Biotech

GranNEX is Mycenax's filgrastim, the biosimilar version of Neupogen, and the recombinant human granulocyte colony-stimulating factor, G-CSF. It can stimulate the growth of the white cell. The development of GranNEX followed the regulatory pathway of the biosimilar, with high biosimilarity to its reference product, and complied with the requirements of the European Medicine Agency. This project is granted by the Ministry of Economic Affairs (MOEA) and selected as the critical path project by the Center for Drug Evaluation (CDE) in Taiwan. Mycenax has completed GranNEX's pre-clinical development and will focus on the application of the new delivery system or new formulation for patient's ease of using GranNEX.

Further product details are provided in the report.

Filgrastim: Therapeutic Assessment

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

  • Major Players in Filgrastim

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

  • 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

Filgrastim 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
  • 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.

Filgrastim: Pipeline Development Activities

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

Report Highlights:

  • The companies and academics are working to assess challenges and seek opportunities that could influence Filgrastim R&D. The therapies under development are focused on novel approaches to treat/improve Filgrastim.
  • In November 2019, Sandoz announced that the US Food and Drug Administration (FDA) approved its biosimilar ZiextenzoTM (pegfilgrastim-bmez).
  • In April 2019, Sandoz announced resubmission of its Biologics License Application (BLA) for a proposed biosimilar pegfilgrastim to the US Food and Drug Administration (FDA) to address an FDA complete response letter received in June 2016.

Filgrastim Biosimilars Report Insights

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

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

Key Players

  • Zydus Cadila
  • Teva Generics
  • Sandoz
  • Reliance Life Sciences
  • Ratiopharm
  • Pfizer
  • Novartis
  • Mycenax Biotech
  • Laboratorio Elea
  • Hexal
  • Harvest Moon Pharmaceuticals
  • Harvest Moon Pharmaceuticals
  • Hangzhou Jiuyuan Gene Engineering
  • Fuji Pharmaceutical
  • Mochida Pharmaceutical
  • Gene Techno Science
  • Emcure Pharmaceuticals
  • Dr Reddy's Laboratories
  • Dong-A ST Co.
  • Claris Lifesciences
  • Bionovis
  • Bionaturis
  • Curaxys
  • Bio-Ker
  • Biocon
  • Mylan
  • Biocad
  • Apotex
  • Aequus
  • CTI BioPharma
  • Accord Healthcare

Key Products

  • G-CSF
  • Tevagrastim
  • Zarzio
  • ReliGrast
  • Ratiograstim
  • Nivestim
  • Zarxio
  • GranNEX
  • Recombinant human granulocyte colony-stimulating factor
  • Filgrastim Hexal
  • Filgrastim BS; FSK-0808; GBS 001
  • Grafeel
  • Leucostim
  • Fegrast
  • Biofigran
  • BNT002
  • BK 0023
  • Nufil
  • Leucostim
  • Grastofil
  • AQB-101;
  • Accofil

Table of Contents

1. Key Insights

2. Filgrastim 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. Filgrastim (Reference Product: Neupogen)

  • 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. Neupogen Biosimilar: Emerging Opportunities

8. Filgrastim: 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. Filgrastim Biosimilars Profiles: By Company

    • 9.1.1. Pfizer
      • Nivestim: Pfizer
      • Product Information
      • Research and Development
      • Other Development Activities
      • General Description Table
    • 9.1.2. Novartis
      • Zarxio: Novartis
      • Product Information
      • Research and Development
      • Other Development Activities
      • General Description Table
    • 9.1.3. Zydus Cadila
      • G-CSF: Zydus Cadila
      • Product Information
      • Research and Development
      • Other Development Activities
      • General Description Table
    • 9.1.4. Bio-Ker
      • BK 0023: Bio-Ker
      • Product Information
      • Research and Development
      • Other Development Activities
      • General Description Table
    • 9.1.5. Sandoz
      • Zarzio: Sandoz
      • Product Information
      • Research and Development
      • Other Development Activities
      • General Description Table

More Companies and products would be added in the final report

10. Filgrastim Biosimilars: Comparative Landscape: By Company

11. Filgrastim 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 Filgrastim
  • 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 Filgrastim
  • 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