Etanercept– Biosimilar Insight, 2022

January 2022 | 60 pages | ID: ED3EC0F7A36CEN
DelveInsight

Abstracts

This report can be delivered to the clients within 24 Hours

DelveInsight’s, “Etanercept– Biosimilar 2022,” report provides comprehensive insights about 20+ companies and 20+ marketed and pipeline drugs in Etanercept 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

Etanercept Understanding

Etanercept: Overview

Etanercept is indicated for the treatment of moderately to severely active rheumatoid arthritis in adults and in chronic moderate to severe plaque psoriasis in patients 4 years of age and older. It is also used to manage signs and symptoms of polyarticular idiopathic arthritis in those aged 2 years and older. Etanercept is also used to manage the symptoms of psoriatic arthritis and ankylosing spondylitis. Dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1. The Fc component of etanercept contains the CH2 domain, the CH3 domain and hinge region, but not the CH1 domain of IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell expression system. It consists of 934 amino acids. It is used to treat or manage a variety of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis (AS), and juvenile idiopathic poly-articular arthritis (JIA).

Etanercept Biosimilars: Drugs Chapters

This segment of the Etanercept 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.

Etanercept Biosimilars: Marketed Drugs

• GP 2015: Sandoz

GP2015 is the second biosimilar of the reference p75 TNF receptor-Fc fusion protein etanercept. It is approved for use in all indications for which reference etanercept is approved, including rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis. GP2015 has similar physiochemical and pharmacodynamic properties to those of reference etanercept, and the pharmacokinetic biosimilarity of the agents has been shown in healthy volunteers. GP2015 demonstrated clinical efficacy equivalent to that of reference etanercept in patients with moderate-to-severe plaque psoriasis; the tolerability, safety and immunogenicity profiles of the two agents were also generally similar.

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

Etanercept Biosimilars: Emerging Drugs

• CHS-0214: Coherus BioSciences

CHS-0214 is being developed in phase III stage of development. Coherus BioSciences (CHRS) and Baxalta (BXLT) announced that CHS-0214, a proposed biosimilar of Enbrel, met its primary endpoint in a confirmatory, double-blind, randomized, and controlled, two-part clinical study. This ongoing study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel in patients with moderate-to-severe rheumatoid arthritis that is inadequately controlled with methotrexate alone.

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

Etanercept: Therapeutic Assessment

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

• Major Players in Etanercept

There are approx. 20+ key companies which are developing the therapies for Etanercept.

• Phases

DelveInsight’s 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

Etanercept 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.

Etanercept: Pipeline Development Activities

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

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Etanercept R&D. The therapies under development are focused on novel approaches to treat/improve Etanercept.
• In June 2020, Mylan and Lupin Limited announced that the European Commission (EC) has granted marketing authorization for Nepexto, a biosimilar to Enbrel (etanercept), for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis.
• In April 2019, Samsung Bioepis announced that the US Food and Drug Administration (FDA) has approved eticovo (etanercept-ykro), a biosimilar referencing ENBREL (etanercept), across all eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis. ETICOVO is Samsung Bioepis’ second anti-TNF biosimilar approved for marketing in the United States (US).

Etanercept Biosimilars Report Insights

• Etanercept Biosimilar Pipeline Analysis
• Therapeutic Assessment
• Sales Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• YL Biologics (Lupin/Yoshida)
• Shanghai CP Guojian Pharmaceutical
• Sandoz
• Samsung Bioepis
• Reliance Life Sciences
• Protalix Biotherapeutics
• Probiomed
• Pfizer
• Nanogen
• Mycenax Biotech
• TSH Biopharm Corp, Taiwan
• Mochida Pharmaceutical
• Merck
• mAbxience
• Lupin
• LG Life Sciences (LG Chem)
• Intas Pharmaceuticals
• Hisun Pharmaceuticals
• Harvest Moon Pharmaceuticals
• Hanwha Chemical
• Coherus BioSciences
• Clover Biopharmaceuticals
• Cipla
• Celltrion
• BioXpress Therapeutics
• Biosidus
• Biocon
• Mylan
• Avesthagen
• AryoGen Pharmed
• Amega Biotech

Key Products

• YLB113
• Etanar
• Qiangke
• Erelzi (GP2015)
• Eticovo (SB4)
• EtanerRel
• PRX-106
• Infinitam
• Lifmior
• Nanercept
• TuNEX (ENIA11)
• Eucept (LBEC0101)
• Brenzys
• mAbx01
• RTXM93
• YLB-113
• Eucept (LBEC0101)
• TNFcept
• Intacept
• AnBaiNuo
• Davictrel (HD203)
• CHS-0214
• SCB-808
• Etacept
• CT-P05
• BX2922
• Avent
• Altebrel
• Enerceptan

Contents

1. KEY INSIGHTS

2. ETANERCEPT 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. ETANERCEPT (REFERENCE PRODUCT: ENBREL )

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. ENBREL BIOSIMILAR: EMERGING OPPORTUNITIES

8. ETANERCEPT: 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. ETANERCEPT BIOSIMILARS PROFILES: BY COMPANY

  9.1.1. Samsung Bioepis
    9.1.1.1. Eticovo (SB4): Samsung Bioepis
      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. Merck
    9.1.2.1. Brenzys: Merck
      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. Pfizer
    9.1.3.1. Lifmior: Pfizer
      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. ETANERCEPT BIOSIMILARS: COMPARATIVE LANDSCAPE: BY COMPANY

11. ETANERCEPT 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