Darbepoetin Alfa Biosimilar Insight

DelveInsight’s, “Darbepoetin alfa– Biosimilar Insight, 2020,” 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. 

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.

Further product details are provided in the report……..

Darbepoetin alfa Biosimilars: Emerging Drugs

  • CJ-40001: HK inno.N

HK inno.N is developing CJ-40001 for the treatment of Anaemia.

Further product details are provided in the report……..

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

DelveInsight’s 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

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

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

 

1. Key Insights

2. 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. Torrent Pharmaceuticals

9.1.1. Darbatitor: Torrent Pharmaceuticals

9.1.1.1. Product Information

9.1.1.2. Research and Development

9.1.1.3. Other Development Activities

9.1.1.4. 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. Overview

11.2. Market Share Analysis

11.3. Competitive Scenario

11.3.1. Product Launches and approval

11.3.2. Partnerships, Collaborations and Agreements

11.3.3. Acquisitions

11.3.4. Expansions

11.3.5. 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 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 Products

List 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

• 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

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