Certolizumab pegol is a Monoclonal Antibody owned by UCB, and is involved in 111 clinical trials, of which 98 were completed, and 13 are ongoing.

Certolizumab pegol (Cimzia) is a Tumor Necrosis Factor Alpha (TNF-a) Inhibitor. It is an immunosuppresent that inhibits tumor necrosis factor alpha (TNF-alpha) to produce anti-inflammatory effects. TNF alpha is a protein produced by the body that is involved in causing inflammation. It controls the activity of other inflammatory chemicals. TNF alpha is found in increased levels in various inflammatory conditions. Inflammation occurs when TNF alpha acts on TNF receptors that are found on the surface of cells. Certolizumab pegol works by stopping TNF alpha from acting on these receptors. This neutralizes the biological activity of TNF-alpha resulting in the healing of inflammation. The drug candidate may exhibit therapeutic intervention by checking the underlying cause of disease progression.

The revenue for Certolizumab pegol is expected to reach a total of $1.7bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Certolizumab pegol NPV Report.

Certolizumab pegol was originated by UCB Celltech and is currently owned by UCB. Astellas Pharma is the other company associated in development or marketing of Certolizumab pegol.

Certolizumab pegol Overview

Certolizumab pegol (Cimzia) is a recombinant Fab antibody fragment, acts as antirheumatic agent. It is formulated as injectable lyophilized powder for solution and pegylated injectable solution for subcutaneous administration. Cimzia in combination with methotrexate (MTX) is indicated for reducing signs and symptoms, inducing major clinical response, and reducing the progression of joint damage as assessed by X-ray, in adult patients with moderately to severely active rheumatoid arthritis (RA), may be used alone for reducing signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis (RA) who do not tolerate MTX, Cimzia alone or in combination with methotrexate (MTX) is indicated for:reducing signs and symptoms and inhibiting the progression of structural damage as assessed by X-ray, in adult patients with moderately to severely active psoriatic arthritis (PsA) who have failed one or more disease-modifying anti-rheumatic drugs (DMARDs), reducing signs and symptoms in adult patients with active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy, for the treatment of adult patients with severe active axial spondyloarthritis, comprising: adults with severe active ankylosing spondylitis who have had an inadequate response, or are intolerant, Non-steroidal anti-inflammatory drugs (NSAIDs), adults with severe active axial spondyloarthritis without radiographic evidence of AS, but with signs Evident inflammation detected by elevated C-reactive protein (CRP) and / or magnetic resonance imaging (MRI), who have had an inadequate response, or are intolerant, to NSAIDs, for reducing signs and symptoms of Crohn’s disease and maintaining clinical  response in adult patients with moderately to severely active disease who have had an inadequate  response to conventional therapy, and non-radiographic axial spondyloarthritis (nr-axSpA), and is indicated to treat plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma for which existing treatment methods are not sufficiently effective.

Certolizumab pegol (Cimzia) is under development as a combination with MTX for the treatment of rheumatoid arthritis in adult patients with severe active and progressive RA not previously treated with MTX or other DMARDs and interstitial cystitis. It is a new biological entity (NBE). It was also under development for the treatment of Crohn's disease and polyarticular juvenile idiopathic arthritis. It was also under development for moderate to severe chronic plaque psoriasis and intestitial cystitis.

Astellas Pharma Overview

Astellas Pharma (Astellas) discovers, develops, manufactures, and commercializes a wide range of pharmaceuticals. The company’s product portfolio comprises marketed products for the treatment of a wide range of urological diseases, infectious diseases, cancer, nephrology, and metabolic diseases, immunodeficiency diseases, and transplantation. Its pipeline possesses drug candidates for the treatment of urothelial cancer; gastric cancer; gastroesophageal junction cancer; anemia associated with chronic kidney disease (CKD) in dialysis; Rheumatoid arthritis and non-dialysis patients; menopause-related vasomotor symptoms (MR-VMS) such as hot flashes and night sweats; and acute myeloid leukemia (AML), among others. It operates in the Americas, Australia, Europe, and Asia and Oceania through a network of subsidiaries and affiliates. Astellas is headquartered in Tokyo, Japan.

The company reported revenues of (Yen) JPY1,296,163 million for the fiscal year ended March 2022 (FY2022), an increase of 3.7% over FY2021. In FY2022, the company’s operating margin was 12.4%, compared to an operating margin of 11.7% in FY2021. In FY2022, the company recorded a net margin of 9.6%, compared to a net margin of 9.7% in FY2021. The company reported revenues of JPY380,394 million for the second quarter ended September 2022, a decrease of 0.4% over the previous quarter.

Quick View – Certolizumab pegol

Report Segments
  • Innovator (NME)
Drug Name
  • Certolizumab pegol
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Central Nervous System
  • Gastrointestinal
  • Immunology
  • Musculoskeletal Disorders
Key Companies
  • Sponsor Company: UCB
  • Originator: UCB Celltech
Highest Development Stage
  • Marketed

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

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.