Cimzia
Publisher: Datamonitor Healthcare
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Drug Overview
Cimzia (certolizumab; UCB/Astellas [also marketed by Dermira in some approved indications]) is a PEGylated humanized monoclonal antibody fragment, with high affinity for both soluble and membrane-bound tumor necrosis factor alpha. Celltech (now UCB) used its proprietary fragments of antibody (FAb) technology to develop Cimzia for use in chronic inflammatory diseases.
Cimzia was originally approved and launched in the US for the treatment of Crohn’s disease in April 2008. In October 2013, the US Food and Drug Administration approved Cimzia for the treatment of adult patients with active ankylosing spondylitis (AS). In the same month, the drug was granted approval in the EU for the treatment of adults with severe active axial spondyloarthritis, comprising severe active AS and severe active non-radiographic axial spondyloarthritis. Cimzia is also indicated for the treatment of rheumatoid arthritis and psoriatic arthritis.
TABLE OF CONTENTS
5 OVERVIEW
5 Drug Overview
6 Product Profiles
6 Cimzia : Crohn’s disease
20 Cimzia : Axial spondyloarthritis (axSpA)
33 Cimzia : Rheumatoid arthritis (RA)
45 Cimzia : Psoriatic arthritis (PsA)
56 Cimzia : Psoriasis
LIST OF FIGURES
13 Figure 39: Filgotinib sales for Crohn’s disease across the US, Japan, and five major EU markets, by country, 2016–25
15 Figure 38: Datamonitor Healthcare’s drug assessment summary of ozanimod in Crohn’s disease
17 Figure 4: Sales of Stelara, key branded anti-TNFs, and Entyvio across the US, Japan, and five major EU markets, by drug, 2016–25
25 Figure 39: Ozanimod sales for Crohn’s disease across the US, Japan, and five major EU markets, by country, 2016–25
27 Figure 42: Risankizumab for Crohn’s disease – SWOT analysis
30 Figure 43: Datamonitor Healthcare’s drug assessment summary of risankizumab in Crohn’s disease
32 Figure 40: Datamonitor Healthcare’s drug assessment summary of risankizumab in Crohn’s disease
40 Figure 7: Price sources and calculations, by country
41 Figure 44: Risankizumab sales for Crohn’s disease across the US, Japan, and five major EU markets, by country, 2016–25
51 Figure 10: Cimzia for psoriatic arthritis – SWOT analysis
53 Figure 47: Datamonitor Healthcare’s drug assessment summary of upadacitinib in Crohn’s disease
63 Figure 10: Cimzia for Crohn’s disease – SWOT analysis
LIST OF TABLES
6 Table 1: Cimzia drug profile
8 Table 2: Cimzia pivotal trial data in Crohn’s disease
11 Table 3: Cimzia late-phase trial data in Crohn’s disease
18 Table 4: Cimzia sales for Crohn’s disease across the US, Japan, and Spain, by country ($m), 2016–25
20 Table 5: Cimzia drug profile
22 Table 6: Cimzia pivotal trial data in axial spondyloarthritis
24 Table 7: Cimzia ongoing late-phase trial in axial spondyloarthritis
34 Table 8: Cimzia drug profile
36 Table 9: Cimzia pivotal trial data in rheumatoid arthritis
38 Table 10: Cimzia late-phase trial data in rheumatoid arthritis
46 Table 11: Cimzia drug profile
48 Table 12: Cimzia pivotal trial data in psoriatic arthritis
57 Table 13: Cimzia drug profile
59 Figure 44: Upadacitinib sales for Crohn’s disease across the US, Japan, and five major EU markets, by country, 2016–25
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