Follitropin alfa– Biosimilar Insight, 2022

January 2022 | 60 pages | ID: F1DAC454FD2AEN
DelveInsight

Abstracts

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DelveInsight’s, “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 ?- and ?-subunits. The ?- and ?-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)

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

Follitropin alfa Biosimilars: Emerging Drugs

• Primapur: IVFarma

IVFarma is developing Primapur for the treatment of Female infertility.

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

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

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

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

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

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

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. DELVEINSIGHT CAPABILITIES

18. DISCLAIMER

19. ABOUT DELVEINSIGHT