表紙
市場調查報告書
商品編碼
973902

Pegfilgrastim - 生物相似藥考察:2020年

Pegfilgrastim- Biosimilar Insight, 2020

出版日期: 按訂單生產 | 出版商: DelveInsight Business Research LLP | 英文 60 Pages | 商品交期: 2-10個工作天內

價格
  • 全貌
  • 簡介
  • 目錄
簡介

本報告提供Pegfilgrastim 生物相似藥形勢調查分析,20家以上的企業,20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 Pegfilgrastim 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 Pegfilgrastim (商品名:Neulasta)

  • 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
  • 用量變更
  • 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 新光柵(Neulasta) 生物相似藥:新興機會

第8章 Pegfilgrastim :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 Pegfilgrastim 生物相似藥簡介:各企業

  • Pfizer
  • Mylan
  • USV

第10章 Pegfilgrastim 生物相似藥比較形勢:各企業

第11章 Pegfilgrastim 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

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

Pegfilgrastim Understanding

Pegfilgrastim: Overview

Pegfilgrastim is a PEGylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue, filgrastim. It is used to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with with non-myeloid cancer receiving myelosuppressive anti-cancer treatment. Some patients with greater risk factors may develop febrile neutropenia from myelosuppressive therapy and are susceptible to an increased risk of developing infections. Although the risk of developing febrile neutropenia is less than 20% in many readily used chemotherapy regimens, infections pose risks of hospitalization and mortalities. Due to the relatively short circulating half-life of filgrastim, a 20 kDa PEG moiety was covalently conjugated to the N-terminus of filgrastim (at the methionine residue) to develop a longer acting version of the drug. Due to a longer half-life and slower elimination rate than filgrastim, pegfilgrastim requires less frequent dosing than filgrastim.

Pegfilgrastim Biosimilars: Drugs Chapters

This segment of the Pegfilgrastim 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.

Pegfilgrastim Biosimilars: Marketed Drugs

  • Nyvepria: Pfizer

Nyvepria is a biosimilar to Neulasta, is approved by the FDA to help reduce the chance of infection due to a low white blood cell count in people with non-myeloid cancer who receive anti-cancer medicines, like chemotherapy, that can cause fever and low white blood cell count. This condition, known as febrile neutropenia, is a common side effect of many types of chemotherapy and lowers the body's ability to defend itself against infections.

Further product details are provided in the report:

Pegfilgrastim Biosimilars: Emerging Drugs

  • PF-06881894: Pfizer

PF-06881894 is a potential biosimilar to Neulasta (Pegfilgrastim) which was initially being developed by Hospira pharma and currently is being developed by Pfizer. The drug is currently in registration phase of development for the treatment of Neutropenia.

Further product details are provided in the report:

Pegfilgrastim: Therapeutic Assessment

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

  • Major Players in Pegfilgrastim

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

  • 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

Pegfilgrastim 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.

Pegfilgrastim: Pipeline Development Activities

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

Report Highlights:

  • The companies and academics are working to assess challenges and seek opportunities that could influence Pegfilgrastim R&D. The therapies under development are focused on novel approaches to treat/improve Pegfilgrastim.
  • In June 2020, Pfizer announced the United States (U.S.) Food and Drug Administration (FDA) has approved Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim). NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • In February 2020, Pfizer confirms the Preregistration for Neutropenia in European Union and in USA.
  • In September 2015, Pfizer announced that it has completed its acquisition of Hospira, Inc

Pegfilgrastim Biosimilars Report Insights

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

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

Key Players

  • Merck & Co
  • Zydus Cadila
  • Virchow Group
  • USV
  • Sandoz
  • Reliance Life Sciences
  • Ratiopharm
  • PharmaEssentia
  • Pfizer
  • Pfenex
  • Nanogen Biopharmaceutical
  • Mylan
  • Mundipharma Biologics
  • Lupin
  • Jiangsu Hengrui Medicine Co
  • Intas Biopharmaceuticals
  • Hospira
  • Harvest Moon Pharmaceuticals
  • Hangzhou Jiuyuan Gene Engineering
  • Gene Techno Science
  • Gedeon Richter
  • Fresenius Kabi
  • Eurofarma Laboratorios
  • ERA Consulting (Coherus Biosciences)
  • Emcure Pharmaceuticals
  • Dr Reddy's Laboratories
  • Dong-A ST
  • Coherus Biosciences
  • CinnaGen
  • Cinfa Biotech
  • Chong Kun Dang
  • Biocure Technology
  • Biocon
  • Apotex
  • Accord Healthcare

Key Products

  • MK-6302
  • Peg G-CSF
  • PEG Neutrogen
  • Grasustek
  • LA-EP2006/Ziextenzo
  • R-TPR-029
  • Filgrastim ratiopharm
  • PEG-GCSF
  • PF-06881894
  • PF-529
  • PEGCYTE
  • Fulphila
  • Cegfila
  • Lupifil-P
  • HHPG-19K
  • Neupeg
  • HSP-130
  • GBS 010
  • RGB-02
  • MSB-11455
  • Recombinant pegfilgrastim
  • Udenyca
  • DRL_PG/ Peg-grafeel
  • Dulastin
  • Udenyca
  • PegaGen
  • B12019/Pelmeg
  • CKD-12101
  • Neutropeg (Apo-Peg)
  • Pelgraz

Table of Contents

1. Key Insights

2. Pegfilgrastim 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. Pegfilgrastim (Reference Product: Neulasta)

  • 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. Neulasta Biosimilar: Emerging Opportunities

8. Pegfilgrastim: 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. Pegfilgrastim Biosimilars Profiles: By Company

    • 9.1.1. Pfizer
      • 9.1.1.1. Nyvepria: 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
      • 9.1.1.2. PF-06881894: Pfizer
      • 9.1.1.2.1. Product Information
      • 9.1.1.2.2. Research and Development
      • 9.1.1.2.3. Other Development Activities
      • 9.1.1.2.4. General Description Table
    • 9.1.2. Mylan
      • 9.1.2.1. Fulphila: Mylan
      • 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. USV
      • 9.1.3.1. Grasustek: USV
      • 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

More Companies and products would be added in the final report

10. Pegfilgrastim Biosimilars: Comparative Landscape: By Company

11. Pegfilgrastim 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 Pegfilgrastim
  • 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 Pegfilgrastim
  • 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