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Follitropin alfa- Biosimilar Insight, 2022

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    Report

  • 60 Pages
  • January 2022
  • Region: Global
  • DelveInsight
  • ID: 5526143
UP TO OFF until Dec 31st 2024
This “Follitropin alfa- Biosimilar 2022” report provides comprehensive insights about 10+ companies and 10+ marketed and pipeline drugs in Follitropin 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

Follitropin alfa Understanding


Follitropin alfa: Overview


Gonal-f (follitropin alfa for injection) is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the α- and β-subunits. The α- and β-subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structure are indistinguishable from those of human follicle stimulating hormone. Recombinant FSH production occurs in genetically modified Chinese Hamster Ovary (CHO) cells cultured in bioreactors. Purification by immunochromatography using an antibody specifically binding FSH results in a highly purified preparation with a consistent FSH isoform profile, and a high specific activity.

Follitropin alfa Biosimilars: Drugs Chapters


This segment of the Follitropin 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.

Follitropin alfa Biosimilars: Marketed Drugs


Bemfola: Gedeon Richter

Bemfola is a medicine that contains the active substance follitropin alfa. It is used to treat the following groups: women who do not produce eggs and who do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs)

Follitropin alfa Biosimilars: Emerging Drugs


Primapur: IVFarma

IVFarma is developing Primapur for the treatment of Female infertility.

Follitropin alfa: Therapeutic Assessment


This segment of the report provides insights about the different Follitropin alfa biosimilars segregated based on following parameters that define the scope of the report, such as:


Major Players in Follitropin alfa


There are approx. 10+ key companies which are developing the therapies for Follitropin 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

Follitropin 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.

Follitropin alfa: Pipeline Development Activities


The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Follitropin 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 Follitropin alfa biosimilar drugs.

Report Highlights

  • The companies and academics are working to assess challenges and seek opportunities that could influence Follitropin alfa R&D. The therapies under development are focused on novel approaches to treat/improve Follitropin alfa.
  • Follitropin alfa Biosimilars Report Insights
  • Follitropin alfa Biosimilar Pipeline Analysis
  • Therapeutic Assessment
  • Sales Assessment
  • Unmet Needs
  • Impact of Drugs

Follitropin 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 Follitropin alfa Biosimilars?
  • How many Follitropin 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 Follitropin alfa biosimilars therapeutics?
  • What are the clinical studies going on for Follitropin alfa biosimilars and their status?
  • What are the key designations that have been granted to the emerging drugs?

Key Players

  • Biocad
  • Finox Biotech
  • CinnaGen
  • Dong-A ST
  • Gema Biotech S.A.
  • MinaPharm Pharmaceuticals
  • IVFarma
  • Merck Serono
  • Teva Pharma
  • Theramex
  • AbbVie
  • Itero Biopharmaceuticals
  • Cadila Healthcare

Key Products

  • Bemfola
  • Cinnal-F
  • DA-3801
  • Folitime
  • Follitropin-alpha
  • Ovaleap
  • Primapur

Table of Contents

1. Key Insights

2. Follitropin 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. Follitropin alfa (Reference Product: Gonal-F)
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. Gonal-F Biosimilar: Emerging Opportunities

8. Follitropin 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. Follitropin alfa Biosimilars Profiles: By Company
9.1.1. Finox Biotech
9.1.1.1. Bemfola: Finox Biotech
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. iVFarma
9.1.2.1. Primapur: iVFarma
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
*More Companies and products would be added in the final report

10. Follitropin alfa Biosimilars: Comparative Landscape: By Company

11. Follitropin 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 Follitropin 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 Follitropin 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:

  • Biocad
  • Finox Biotech
  • CinnaGen
  • Dong-A ST
  • Gema Biotech S.A.
  • MinaPharm Pharmaceuticals
  • IVFarma
  • Merck Serono
  • Teva Pharma
  • Theramex
  • AbbVie
  • Itero Biopharmaceuticals
  • Cadila Healthcare