Etanercept biosimilar is under clinical development by Lupin and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Etanercept biosimilar’s likelihood of approval (LoA) and phase transition for Rheumatoid Arthritis took place on 09 Feb 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Etanercept biosimilar Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Etanercept biosimilar overview

Etanercept (Rymti, Etera, Nepexto) is a 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, acts as an anti-rheumatic agent. It is formulated as solution for subcutaneous route of administration. Etanercept is indicated for the treatment of moderate to severe rheumatoid arthritis and juvenile idiopathic arthritis in adults and children, in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate, as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate, treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate, treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate, treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy, treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate, psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease, treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy, treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs), treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA), and treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.

Etanercept biosimilar is under development for the treatment of Coronavirus disease 2019 (COVID-19), rheumatoid arthritis. It is administered through subcutaneous route.

Lupin overview

Lupin develops and manufactures generic and branded formulations, biotechnology products, and active pharmaceutical ingredients (APIs). It has expertise in the areas of cardiovascular, asthma, diabetic management, pediatrics, central nervous system, gastro-intestinal, anti-infectives, nonsteroidal anti-inflammatory drugs (NSAIDs), anti-TB, and cephalosporins. The company undertakes extensive research and development activities of pharmaceuticals for the treatment of migraine, gastrointestinal, psoriasis, central nervous system, cardiovascular, tuberculosis, diabetes, inflammation and others. Lupin also develops value-added generic pharmaceuticals based on its platform technologies. The company along with its subsidiaries operates manufacturing facilities in India, the US, Mexico, and Brazil. Lupin is headquartered in Mumbai, Maharashtra, India.

Quick View Etanercept biosimilar LOA Data

Report Segments
  • Biosimilar
Drug Name
  • Etanercept biosimilar
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Immunology
  • Infectious Disease
  • Musculoskeletal Disorders
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.