This “Epoetin alfa- Biosimilar 2022” report provides comprehensive insights about 15+ companies and 20+ marketed and pipeline drugs in Epoetin 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.
Erythropoietin is a glycoprotein which stimulates red blood cell production. It is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin. Epogen (epoetin alfa) injection for intravenous or subcutaneous administration is formulated as a sterile, clear, colorless liquid in vials in multiple formulations.
This segment of the Epoetin 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.
Binocrit: Sandoz
Binocrit (epoetin alfa) is a prescription medicine that stimulates the bone marrow to produce red blood cells. In April 2016, Sandoz announced that the European Commission (EC) has approved a type II variation for the addition of a subcutaneous (s.c.) route of administration in Binocrit's (epoetin alfa) nephrology indication.
Epoimmun: Biosidus
Epoimmun is a synthetic form of human erythropoietin, used to treat anemia. Biosidus recombinant human erythropoietin is their flagship product which is obtained by mass cell culture of genetically modified mammalian cells.
UB 851: UBI Pharma
UB-851 is a recombinant human EPO biosimilar. Its highly glycosylated structure, with sialic acid content being the key factor for the in vivo half-life of EPO, makes the product development challenging. Unlike small molecule drugs, biosimilars have complicated structures and large molecular weights. The bioactivity, safety, and efficacy of biosimilars are closely related to the manufacturing process, which is very difficult to replicate.
There are approx. 15+ key companies which are developing the therapies for Epoetin alfa.
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 Epoetin 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 Epoetin alfa biosimilar drugs.
Geography Covered
- Global coverage
Epoetin alfa Understanding
Epoetin alfa: Overview
Erythropoietin is a glycoprotein which stimulates red blood cell production. It is produced in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced. The product contains the identical amino acid sequence of isolated natural erythropoietin. Epogen (epoetin alfa) injection for intravenous or subcutaneous administration is formulated as a sterile, clear, colorless liquid in vials in multiple formulations.
Epoetin alfa Biosimilars: Drugs Chapters
This segment of the Epoetin 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.
Epoetin alfa Biosimilars: Marketed Drugs
Binocrit: Sandoz
Binocrit (epoetin alfa) is a prescription medicine that stimulates the bone marrow to produce red blood cells. In April 2016, Sandoz announced that the European Commission (EC) has approved a type II variation for the addition of a subcutaneous (s.c.) route of administration in Binocrit's (epoetin alfa) nephrology indication.
Epoimmun: Biosidus
Epoimmun is a synthetic form of human erythropoietin, used to treat anemia. Biosidus recombinant human erythropoietin is their flagship product which is obtained by mass cell culture of genetically modified mammalian cells.
Epoetin alfa Biosimilars: Emerging Drugs
UB 851: UBI Pharma
UB-851 is a recombinant human EPO biosimilar. Its highly glycosylated structure, with sialic acid content being the key factor for the in vivo half-life of EPO, makes the product development challenging. Unlike small molecule drugs, biosimilars have complicated structures and large molecular weights. The bioactivity, safety, and efficacy of biosimilars are closely related to the manufacturing process, which is very difficult to replicate.
Epoetin alfa: Therapeutic Assessment
This segment of the report provides insights about the different Epoetin alfa biosimilars segregated based on following parameters that define the scope of the report, such as:
Major Players in Epoetin alfa
There are approx. 15+ key companies which are developing the therapies for Epoetin alfa.
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
Epoetin 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.
Epoetin alfa: Pipeline Development Activities
The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Epoetin 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 Epoetin alfa biosimilar drugs.
Report Highlights
- The companies and academics are working to assess challenges and seek opportunities that could influence Epoetin alfa R&D. The therapies under development are focused on novel approaches to treat/improve Epoetin alfa.
- In May 2018, Pfizer announced the United States (U.S.) Food and Drug Administration (FDA) approved RETACRIT (epoetin alfa-epbx), a biosimilar to Epogen and Procrit (epoetin alfa)1, for all indications of the reference product. RETACRIT is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the US.
- In August 2018, Stada announced that it is increasing its presence in the biosimilar sphere by becoming the majority shareholder in Bioceuticals, a venture capital-funded organization created by Stada to carry out its biosimilar programs.
Epoetin alfa Biosimilars Report Insights
- Epoetin alfa Biosimilar Pipeline Analysis
- Therapeutic Assessment
- Sales Assessment
- Unmet Needs
- Impact of Drugs
Epoetin 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 Epoetin alfa Biosimilars?
- How many Epoetin 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 Epoetin alfa biosimilars therapeutics?
- What are the clinical studies going on for Epoetin alfa biosimilars and their status?
- What are the key designations that have been granted to the emerging drugs?
Key Players
- Zydus Cadila
- Wockhardt
- UBI Pharma
- Sun Pharmaceutical Industires
- Stada Arzneimittel
- Sedico
- Sandoz
- Reliance Life Sciences
- Pfizer (Hospira)
- Duopharma
- Nanogen
- Medice Arzneimittel Pütter
- LG Chem
- Hexal
- Emcure
- Dragon Pharmaceutical
- Claris Lifesciences
- Blau Farmaceutica
- Biosidus
- Biocon
- Biocad
- Apotex
- Amega Bitoech
- Johnson & Johnson
- PanGen
Key Products
- EPO
- Wepox
- UB-851
- Ceriton
- Silapo
- Epoetin 2000 I.U.
- Binocrit
- Epostim
- ReliPoietin
- Retacrit
- Erisa (PDA10)
- Nanokine
- Abseamed
- Espogen
- Epoetin alfa Hexal
- Epofer
- BR 05001
- Epotin
- Eritromax
- Epoimmun
- Erypro
- Erythropoietin alfa biosimilar
- APO-EPO
- Recombinant erythropoietin
- Epoetin alfa - ProLease
- PDA 10
Table of Contents
1. Key Insights2. Epoetin 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. Epoetin alfa (Reference Product: Epogen)
5.1. Product Overview
5.2. Indications
5.3. Mechanism of Action
5.4. Dosage and Administration
5.5. Dosage and Strengths
5.6. Dose Modification
5.7. Route of Synthesis
5.8. Pharmacology
5.9. Pharmacodynamics
5.10. Pharmacokinetics
5.11. Adverse Reactions
5.12. Product Snapshot
5.13. Development Milestones
6. Regulatory Milestones
6.1. Approvals
6.2. Research and Development
6.3. Clinical Trials Information
6.4. Safety and Efficacy
7. Epogen Biosimilar: Emerging Opportunities
8. Epoetin 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. Epoetin alfa Biosimilars Profiles: By Company
9.1.1. PanGen Biotech
9.1.1.1. Erisa (PDA10): PanGen Biotech/Duopharma
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. Epostim: 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
9.1.2.2. ReliPoietin: Reliance Life Sciences
9.1.2.2.1. Product Information
9.1.2.2.2. Research and Development
9.1.2.2.3. Other Development Activities
9.1.2.2.4. General Description Table
*More Companies and products would be added in the final report
10. Epoetin alfa Biosimilars: Comparative Landscape: By Company
11. Epoetin 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 Non Muscle Invasive Bladder Cancer
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 Non Muscle Invasive Bladder Cancer
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:
- Zydus Cadila
- Wockhardt
- UBI Pharma
- Sun Pharmaceutical Industires
- Stada Arzneimittel
- Sedico
- Sandoz
- Reliance Life Sciences
- Pfizer (Hospira)
- Duopharma
- Nanogen
- Medice Arzneimittel Pütter
- LG Chem
- Hexal
- Emcure
- Dragon Pharmaceutical
- Claris Lifesciences
- Blau Farmaceutica
- Biosidus
- Biocon
- Biocad
- Apotex
- Amega Bitoech
- Johnson & Johnson
- PanGen
