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Somatotropin - Biosimilar Insight, 2020

August 2020 | 70 pages | ID: S113FDAF5E13EN
DelveInsight

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DelveInsight’s, “Somatropin – Biosimilar Insight, 2020,” report provides comprehensive insights about 10+ companies and 10+ marketed and pipeline drugs in Somatropin 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
Somatropin Understanding

Somatropin: Overview

Somatropin is used to treat growth failure in children and adults who lack natural growth hormone. This includes people with short stature due to Noonan syndrome, Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes. hGH binds to the human growth hormone receptor (GHR). Upon binding, hGH causes dimerization of GHR, activation of the GHR-associated JAK2 tyrosine kinase, and tyrosyl phosphorylation of both JAK2 and GHR. These events recruit and/or activate a variety of signaling molecules, including MAP kinases, insulin receptor substrates, phosphatidylinositol 3' phosphate kinase, diacylglycerol, protein kinase C, intracellular calcium, and Stat transcription factors. These signaling molecules contribute to the GH-induced changes in enzymatic activity, transport function, and gene expression that ultimately culminate in changes in growth and metabolism.

Somatropin Biosimilars: Drugs Chapters

This segment of the Somatropin 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.

Somatropin Biosimilars: Marketed Drugs
  • Omnitrope: Sandoz
Omnitrope (somatropin [rDNA origin] injection) is a form of human growth hormone used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, short stature at birth with no catch-up growth, and other causes.

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

Somatropin Biosimilars: Emerging Drugs
  • Somatropin beta-1b biosimilar: Harvest Moon Pharmaceuticals
Harvest Moon Pharmaceuticals is developing Somatropin beta-1b biosimilar for the treatment of Multiple sclerosis.

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

Somatropin: Therapeutic Assessment

This segment of the report provides insights about the different Somatropin biosimilars segregated based on following parameters that define the scope of the report, such as:
  • Major Players in Somatropin
There are approx. 10+ key companies which are developing the therapies for Somatropin.
  • 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
Somatropin 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
  • Intramuscular
  • 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.

Somatropin: Pipeline Development Activities

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

Report Highlights
  • The companies and academics are working to assess challenges and seek opportunities that could influence Somatropin R&D. The therapies under development are focused on novel approaches to treat/improve Somatropin.
Somatropin Biosimilars Report Insights
  • Somatropin Biosimilar Pipeline Analysis
  • Therapeutic Assessment
  • Sales Assessment
  • Unmet Needs
  • Impact of Drugs
Somatropin 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 Somatropin Biosimilars?
  • How many Somatropin 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 Somatropin biosimilars therapeutics?
  • What are the clinical studies going on for Somatropin biosimilars and their status?
  • What are the key designations that have been granted to the emerging drugs?
Key Players
  • USV
  • Sedico
  • Sandoz
  • rEVO Biologics
  • Reliance Life Sciences
  • Polus BioPharm
  • Pfizer
  • Inbiopro Solutions
  • Harvest Moon Pharmaceuticals
  • Cristalia
  • CinnaGen
  • Biosidus
  • BioPartners
  • Bio-Ker
  • AryaTinaGene
  • Amega Biotech
Key Products
  • Human growth hormone biosimilar
  • Somatropin (rDNA origin)
  • Omnitrope
  • Human growth hormone
  • R-TPR-007
  • SomatoRel
  • PDP805
  • Genotonorm
  • IBPB 003HH
  • Somatotropin biosimilar
  • r-hGH Cristalia
  • Cinnatropin
  • Growmax
  • Valtropin
  • Recombinant somatropin
  • Somatropin biosimilar
  • Recombinant human growth hormone
1. KEY INSIGHTS

2. SOMATROPIN 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. SOMATROPIN (REFERENCE PRODUCT: GENOTROPIN)

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. GENOTROPIN BIOSIMILAR: EMERGING OPPORTUNITIES

*More variants of Somatropin would be added in the final report

8. SOMATROPIN: 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. SOMATROPIN BIOSIMILARS PROFILES: BY COMPANY

  9.1.1. Sandoz
    9.1.1.1. Omnitrope: Sandoz
      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. Pfizer
    9.1.2.1. Genotonorm: Pfizer
      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. SOMATROPIN BIOSIMILARS: COMPARATIVE LANDSCAPE: BY COMPANY

11. SOMATROPIN 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

LIST OF TABLES

Table 1 Total Products for Somatropin
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 Somatropin
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


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