Etanercept - Biosimilar Insight, 2024

This “Etanercept - Biosimilar Insight, 2024” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in Etanercept pipeline landscape. It covers the 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- Biosimilar Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Etanercept pipeline landscape is provided which includes the disease overview and Etanercept treatment guidelines. The assessment part of the report embraces, in depth Etanercept commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Etanercept collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

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.

Etanercept Biosimilars: Emerging Drugs

SBDM-01: Shilpa Biologicals

Shilpa Biologicals is developing an etanercept biosimilar, SBDM-01, which is currently under clinical development. The drug candidate acts by targeting tumor necrosis factor (TNFR) receptor. The biosimilar is being studied in the Phase I stage of Clinical trial evaluation for the treatment of various autoimmune diseases, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

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. 15+ key companies which are developing the therapies for Etanercept.

Phases

DelveInsight’s report covers around 15+ 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.

Etanercept 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 December 2023, mAbxience announced a strategic licensing agreement with Intas Pharmaceuticals Ltd, a leading multinational pharmaceutical company. Under this collaboration, Intas will hold the rights to commercialize Etanercept through its affiliates for the treatment of various autoimmune diseases, in more than 150 countries across the globe, including Europe and the United States.
• In March 2020, YISAIPU was approved by the National Agency of Drug and Food Control (NA-DFC) in Indonesia for launch, adding another overseas market for the product.

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

• Sandoz
• Lupin
• Intas Biopharmaceuticals
• Merck & Co. /Samsung Bioepis
• AryoGen Pharmed
• Rus Biopharm
• Shanghai Celgen

Key Products

• GP2015
• YLB-113 (RYMTI; NEPEXTO)
• INTACEPT
• BRENZYS (ETICOVO; BENPALI)
• ALTEBREL
• Etanercept Biosimilar
• Qiangke

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