Pegfilgrastim Biosimilar Insight

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

 

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 Table

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

• 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

  • Tags:
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  • Pegfilgrastim Mechanism of Action
  • What is Pegfilgrastim
  • Pegfilgrastim Neulasta
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  • Pegfilgrastim Generic
  • Pegfilgrastim Biosimilars approval
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