This “Pegfilgrastim- Biosimilar 2022” 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.
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.
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.
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.
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.
There are approx. 20+ key companies which are developing the therapies for Pegfilgrastim.
The report covers around 20+ products under different phases of clinical development like
The drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
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.
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Pegfilgrastim biosimilar drugs.
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.
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.
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
The 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
The 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 Answered
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 Insights2. 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. Publisher Capabilities
18. Disclaimer
19. About the PublisherList 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 ProductsList 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
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- 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
