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The article GP2015: An Etanercept Biosimilar, written by Emma D. Deeks, was originally published Online First without open access. After publication in volume 31, issue 6, pages 555–558 HEXAL AG requested that the article be Open Choice to make the article an open access publication. Post-publication open access was funded by HEXAL AG. The article is forthwith distributed under the terms of the Creative...
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, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis. GP2015 has similar...
SB2 is a biosimilar of the reference anti-TNF-α antibody infliximab. In May 2015, it was approved in the EU for use in all indications for which reference infliximab is approved, including rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis. It is also approved in these indications in several other countries, including Korea, the USA...
CT-P10 (Truxima™) is the first biosimilar of the reference monoclonal anti-CD20 antibody rituximab. It is approved for use in all indications for which reference rituximab is approved, including follicular lymphoma (FL), diffuse large B-cell non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. CT-P10 has similar...
Certolizumab pegol (Cimzia®) is a subcutaneously administered polyethylene glycolylated (PEGylated) antigen-binding fragment of a recombinant human monoclonal antibody that selectively neutralizes TNFα. The drug is indicated for a variety of inflammatory autoimmune diseases, including Crohn’s disease (CD), rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), based...
Infliximab biosimilar (CT-P13/infliximab-dyyb; Remsima®, Inflectra®) is approved in several countries for use in all indications for which reference infliximab (Remicade®) is approved, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, psoriasis, Crohn’s disease, and ulcerative colitis. Clinical data contributing to the EU approval of infliximab biosimilar were...
Mepolizumab (Nucala®) is a humanized monoclonal antibody against interleukin-5, a cytokine involved in the development, recruitment and activation of eosinophils (cellular mediators of airway inflammation, hyper-responsiveness and tissue remodelling). The drug is indicated as an add-on treatment for severe eosinophilic asthma, on the basis of its clinical benefit in this setting in the placebo-controlled...
Ranibizumab (Lucentis®) is the first inhibitor of vascular endothelial growth factor (VEGF)-A licensed for the treatment of visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (i.e. myopic CNV). The drug inhibits biologically active isoforms of VEGF-A and is administered via intravitreal injection, with the number of treatments required depending on disease activity...
Sunitinib inhibits several receptor tyrosine kinases involved in cancer growth, metastasis, and neoangiogenesis, with its active metabolite (SU012662) demonstrating similar potency. In a randomized, double-blind, multinational, phase III trial, continuous treatment with oral sunitinib 37.5 mg/day significantly prolonged median progression-free survival time (primary end-point) ≈2-fold relative to...
Menveo® is a quadrivalent meningococcal polysaccharide conjugate vaccine containing the four Neisseria meningitidis capsular polysaccharides, A, C, W135, and Y, each conjugated to the mutant diphtheria toxin, known as crossreactive material 197 (CRM197). Administration of a single dose of the Menveo® vaccine elicited a strong immune response against all four vaccine serogroups in adolescents and adults...
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