Etanercept Biosimilars

DelveInsight’s, “Etanercept Biosimilar Insight, 2025” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in Etanercept pipeline landscape. It covers the Etanercept Pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Etanercept Therapeutics Assessment by product type, Etanercept Mechanism of Action, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Etanercept Biosimilars Insights

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 market report encloses its detailed analysis of various drugs in different stages of clinical development,  Etanercept MOA, including  Etanercept MOA 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

• 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.

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 Etanercept Companies

There are approx. 15+ key Etanercept Companies that are developing the Etanercept Therapies.

Phases

DelveInsight’s report covers around 15+ Etanercept 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

The 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

Etanercept 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 Etanercept Biosimilar Report provides insights into different therapeutic candidates in the 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 Etanercept 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 Etanercept Companies and academics are working to assess challenges and seek opportunities that could influence Etanercept R&D. The Etanercept 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
• Etanercept Therapeutic Assessment
• Sales Assessment
• Etanercept Unmet Needs
• Impact of Etanercept Drugs

Etanercept Biosimilar Report Assessment

• Etanercept Marketed Product profiles
• Etanercept Pipeline Product Profiles
• Etanercept Therapeutic Assessment
• Etanercept Pipeline Assessment
• Sales Assessment
• Inactive Etanercept Drugs assessment
• Etanercept Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many Etanercept 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 Etanercept drugs?

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