This “Darbepoetin alfa- Biosimilar 2022” report provides comprehensive insights about 10+ companies and 10+ marketed and pipeline drugs in Darbepoetin alfa 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.
Human erythropoietin with 2 aa substitutions to enhance glycosylation (5 N-linked chains), 165 residues (MW=37 kD). Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. Binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.
This segment of the Darbepoetin alfa 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.
Darbatitor: Torrent Pharmaceuticals
Darbatitor 40mcg Injection is used in the treatment of anemia that may have occurred due to chronic kidney disease or chemotherapy. It works by stimulating the bone marrow to produce more red blood cells.
CJ-40001: HK inno.N
HK inno.N is developing CJ-40001 for the treatment of Anaemia.
There are approx. 10+ key companies which are developing the therapies for Darbepoetin alfa.
The report covers around 10+ 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 Darbepoetin alfa 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 Darbepoetin alfa biosimilar drugs.
Geography Covered
- Global coverage
Darbepoetin alfa Understanding
Darbepoetin alfa: Overview
Human erythropoietin with 2 aa substitutions to enhance glycosylation (5 N-linked chains), 165 residues (MW=37 kD). Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. Erythropoietin interacts with progenitor stem cells to increase red cell production. Binding of erythropoietin to the erythropoietin receptor leads to receptor dimerization, which facilitates activation of JAK-STAT signaling pathways within the cytosol. Activated STAT (signal transducers and activators of transcription) proteins are then translocated to the nucleus where they serve as transcription factors which regulate the activation of specific genes involved in cell division or differentiation.
Darbepoetin alfa Biosimilars: Drugs Chapters
This segment of the Darbepoetin alfa 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.
Darbepoetin alfa Biosimilars: Marketed Drugs
Darbatitor: Torrent Pharmaceuticals
Darbatitor 40mcg Injection is used in the treatment of anemia that may have occurred due to chronic kidney disease or chemotherapy. It works by stimulating the bone marrow to produce more red blood cells.
Darbepoetin alfa Biosimilars: Emerging Drugs
CJ-40001: HK inno.N
HK inno.N is developing CJ-40001 for the treatment of Anaemia.
Darbepoetin alfa: Therapeutic Assessment
This segment of the report provides insights about the different Darbepoetin alfa biosimilars segregated based on following parameters that define the scope of the report, such as:
Major Players in Darbepoetin alfa
There are approx. 10+ key companies which are developing the therapies for Darbepoetin alfa.
Phases
The report covers around 10+ 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
Darbepoetin alfa 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.
Darbepoetin alfa: Pipeline Development Activities
The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Darbepoetin alfa 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 Darbepoetin alfa biosimilar drugs.
Report Highlights
- The companies and academics are working to assess challenges and seek opportunities that could influence Darbepoetin alfa R&D. The therapies under development are focused on novel approaches to treat/improve Darbepoetin alfa.
- In March 2020, CJ Healthcare, a subsidiary of Kolmar Korea, announced that it has changed the company name to HK inno.N on the occasion of its 36th anniversary.
- Darbepoetin alfa Biosimilars Report Insights
- Darbepoetin alfa Biosimilar Pipeline Analysis
- Therapeutic Assessment
- Sales Assessment
- Unmet Needs
- Impact of Drugs
Darbepoetin alfa 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 Darbepoetin alfa Biosimilars?
- How many Darbepoetin alfa 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 Darbepoetin alfa biosimilars therapeutics?
- What are the clinical studies going on for Darbepoetin alfa biosimilars and their status?
- What are the key designations that have been granted to the emerging drugs?
Key Players
- Torrent Pharmaceuticals
- Reliance Life Sciences
- Nichi-Iko Pharmaceutical
- Kyowa Kirin
- Kissei Pharmaceutical
- Dr Reddy's
- Dong-A ST
- CJ Healthcare
- Cipla
- Chong Kun Dang Pharmaceutical
- Biocad
- Avesthagen Pharma
- 3SBio
Key Products
- Darbatitor
- DarbeRel
- AP 032
- Darbepoetin Alfa Injection Syringe
- JR-131
- Cresp
- DA‑3880
- CJ-40001
- Actorise
- CKD-11101
- BCD 066
- Avdesp
- NuPIAO
Table of Contents
1. Key Insights2. Darbepoetin alfa 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. Darbepoetin alfa (Reference Product: Aranesp)
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. Aranesp Biosimilar: Emerging Opportunities
8. Darbepoetin alfa: 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. Darbepoetin alfa Biosimilars Profiles: By Company
9.1.1. Torrent Pharmaceuticals
9.1.1.1. Darbatitor: Torrent Pharmaceuticals
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. Reliance Life Sciences
9.1.2.1. DarbeRel: Reliance Life Sciences
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. CJ Healthcare
9.1.3.1. CJ-40001: CJ Healthcare
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. Darbepoetin alfa Biosimilars: Comparative Landscape: By Company
11. Darbepoetin alfa 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 Darbepoetin alfa
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 Darbepoetin alfa
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:
- Torrent Pharmaceuticals
- Reliance Life Sciences
- Nichi-Iko Pharmaceutical
- Kyowa Kirin
- Kissei Pharmaceutical
- Dr Reddy’s
- Dong-A ST
- CJ Healthcare
- Cipla
- Chong Kun Dang Pharmaceutical
- Biocad
- Avesthagen Pharma
- 3SBio
