Post Hoc Analysis Showed CIMZIA Resulted in Meaningful Efficacy for RA Patients
UCB`s Biologic Cimzia (certolizumab pegol) Receives Approval in the U.S.
UCB's Biologic Cimzia (Certolizumab Pegol) Receives Approval in the U.S.
CAMBRIDGE, Mass and SOLNA, Sweden, Feb. 07, 2022 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Xbrane Biopharma AB (STO: XBRANE) today announced that they have entered into a commercialization and license agreement to develop, manufacture, and commercialize Xcimzane™, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA® (certolizumab pegol)1.
· First results from the Phase 3 BE SURE study will be presented showing superior skin clearance with bimekizumab compared to Humira[®] (adalimumab) in patients with moderate-to-severe plaque psoriasis
CIMZIA® (certolizumab pegol) is a subcutaneous infusion indicated for the treatment of adults with moderate-to-severe plaque psoriasis.
The European Medicines Agency has expanded the existing approval of UCB’s Cimzia (certolizumab pegol) to cover the treatment of axial spondyloarthritis (axSpA) with a reduced maintenance dose of 200 mg every four weeks in patients who have achieved sustained remission after taking a 200mg dose every two weeks or a 400mg dose every four weeks for a year.
· European label extended to include a dose reduction option for the treatment of adult patients with axial spondyloarthritis (axSpA), including non-radiographic and radiographic axSpA, who are in sustained remission after one year of CIMZIA[®] (certolizumab pegol) treatment,[1] underpinned by results of the Phase 3b C-OPTIMISE study
ATLANTA and PARSIPPANY, N.J., July 7, 2020 /PRNewswire/ -- UCB and Ferring Pharmaceuticals Inc. today announced they have entered into a co-promotion agreement to commercialize the prefilled syringe formulation of CIMZIA® (certolizumab pegol) in the United States, specifically for the treatment of Crohn's disease (CD). Ferring will take over marketing, sales promotion, and field medical affairs activities. UCB will continue to be responsible for all product-related activities, including revenue recognition. CIMZIA is an injectable biologic treatment option for adults with moderate to severe Crohn's disease with inadequate response to conventional therapy. UCB will continue to promote and to commercialize the lyophilized formulation of CIMZIA for all indications as well as the prefilled syringe formulation for CIMZIA's rheumatology and dermatology indications.
Bio-Rad Laboratories, Inc. has announced the launch of a range of anti-certolizumab pegol inhibitory antibodies to support the development of assays for therapeutic drug monitoring of tumor necrosis factor (TNF) alpha inhibitors. By extending its offering to include anti-certolizumab pegol antibodies, Bio-Rad offers critical reagents to support the development of anti-drug antibody (ADA) assays for all five marketed TNF alpha inhibitor biologics and their biosimilars.