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Adalimumab Biosimilar Idacio Launched Germany PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Adalimumab Biosimilar Idacio Launched Germany articles that have been published worldwide.
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Antidrug antibody (ADA) development is known to occur with adalimumab treatment and impacts adalimumab exposure. Here, we compare the impact of immunogenicity on pharmacokinetics (PK) across two randomized PK studies of GP2017, an approved biosimilar adalimumab, in healthy subjects.
FKB327 (Hulio) is a biosimilar of the reference monoclonal anti-TNFα antibody adalimumab, and is approved in the EU for use in the same indications as reference adalimumab. FKB327 has similar physicochemical and pharmacodynamic properties to those of reference adalimumab, and pharmacokinetic equivalence was shown in healthy volunteers and patients with moderate-to-severe rheumatoid arthritis (RA) despite methotrexate therapy. FKB327 demonstrated equivalent clinical efficacy to that of reference adalimumab ...
Adalimumab has emerged as a useful drug for treating patients with Crohn's disease (CD) and ulcerative colitis (UC), not responding to conventional therapy. There is limited data on effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease (IBD).
Recombinant antibodies have emerged over the last few decades as the fastest growing class of therapeutic proteins for autoimmune diseases. Post-translation modifications of antibodies produced by human cell lines are highly consistent with those existing in natural human proteins and this is a major advantage of utilizing these cell lines. Cinorra is a biosimilar form of the antibody Adalimumab, which is an antagonist of TNF-α used for the treatment of autoimmune diseases. Adalimumab and Cinorra were prod...
Tumor necrosis factor (TNF-alpha) inhibitors, such as adalimumab, have shown success in treating autoimmune inflammatory diseases but are associated with substantial financial burdens to the healthcare system. Biosimilars, which are highly similar to biologic agents, offer the potential to reduce the financial burden of treatment. In the case of TNF-alpha inhibitors, they may also offer improved stability and enable prolonged use. SB5, an adalimumab biosimilar, has shown equivalent efficacy and comparable s...
RTXM83 is a rituximab biosimilar with proven clinical safety and efficacy. It is the first rituximab biosimilar developed and approved in South America and is currently marketed in several Latin American, Middle Eastern and African countries.
PYRAMID was an international multicenter, noninterventional, postmarketing registry assessing long-term safety and effectiveness of adalimumab (Humira), as used in routine clinical practice.
To compare different methods of antidrug antibody (ADA) against adalimumab detection in ankylosing spondylitis (AS) patients and the impact of ADA on adalimumab drug levels and mean ASDAS-CRP.
SB2, an infliximab (IFX) biosimilar to the reference infliximab (R.I.) product (Remicade), received approval in the European Union for all IFX indications. Many decision algorithms based on the measurement of IFX trough levels and antibodies to infliximab are being increasingly used to optimize IFX treatment. The aim of our study was to evaluate whether the biosimilar SB2 could be efficiently monitored using the LISA-TRACKER IFX and anti-IFX assays developed by Theradiag (Croissy Beaubourg, France).
There are two products in which infliximab is the active pharmaceutical ingredient. These are Remicade (INF; reference product) and Remsima™/Inflectra™ (CT-P13; infliximab biosimilar). Remsima™/Inflectra™ are bioidentical products. Different recommendations have been made for the clinical solutions of each brand (Remicade or Remsima™/Inflectra™) despite the manufacturer of the biosimilar claiming high levels of similarity to the innovator.
The approval of the etanercept biosimilar SB4 (Brenzys, Benepali; Samsung Bioepis Co., Ltd.) for psoriasis and psoriatic arthritis (PsA) was automatically obtained on the basis of the demonstration of quality, biological activity, efficacy, safety, and immunogenicity similarity to the reference etanercept in the treatment of rheumatoid arthritis (1, 2). Being the development of biosimilars a significant opportunity to decrease medical care cost and increase treatment options (3), extrapolation of clinical d...
Reliable monitoring of clinical relevant anti-drug antibodies is fundamental in the follow-up of patients under adalimumab treatment. The aim of this study is to compare anti-adalimumab antibodies by using three methods based on different technologies. A cross-sectional study was performed in 50 patients with rheumatoid arthritis (RA) treated with adalimumab. Anti-adalimumab antibodies were detected in patients' sera by different techniques: bridging ELISA, reporter gene assay (RGA), and surface plasmon res...
There is evidence that it is safe and effective for patients with inflammatory bowel diseases (IBD) to switch from maintenance therapy with an original infliximab drug to a biosimilar, but little is known about outcomes of reverse switches and/or multiple switches. We aimed to evaluate the effects of a reverse switch (from a biosimilar to Remicade) in a real-life cohort.
CT-P16 is a candidate biosimilar of bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor that is used in the treatment of a range of advanced solid cancers.
Biological therapy is currently widely used to treat IBD. Infliximab, adalimumab and golimumab are currently licensed anti-TNF therapies. Biosimilar anti-TNF monoclonal antibodies are increasingly used. Anti-TNF therapies are widely used and their adverse effects are well characterised, and may cause significant morbidity and mortality in a small proportion of exposed patients. Gastroenterologists need to understand the mechanisms for these effects, recognise these swiftly and manage such events appropriate...
In our work entitled "Adalimumab-based treatment versus DMARDs for venous thrombosis in Behçet syndrome. A retrospective study of 70 patients with vascular involvement" , we showed that Adalimumab (ADA)-based regimen is more effective and rapid than disease modifying anti-rheumatic drugs (DMARDs) in inducing resolution of venous thrombosis in patients with Behçet syndrome (BS), also allowing significant reduction of steroid exposure. This article is protected by copyright. All rights reserved.
Biosimilars are here to stay, but whether they will enjoy widespread uptake remains to be seen. The FDA sets a high bar for approval of biosimilar products, yet many clinicians remain skeptical about the efficacy and safety of these agents. Favorable experience with >30 biosimilars in Europe provides some reassurance that these agents are safe and effective and can be substituted for the reference product.
The development of Bevacizumab (Avastin) biosimilar products has grown rapidly over the last ten years as the original Avastin's patent will expire soon. The approval of Avastin biosimilars requires the demonstration of similarity between the biosimilar and the reference product. To support pre-clinical and clinical studies, pharmacokinetic (PK) assays are required to measure the biosimilar and Avastin with comparable precision and accuracy. The PK assay of Avastin employed by Genentech was a Sandwich ELISA...
We present an adalimumab-related dental implant surgical-site infection. A 55-year-old patient with a history of twice-weekly adalimumab subcutaneous injections for ulcerative colitis underwent mandibular extractions and placement of 5 immediate dental implants. She experienced intraoral purulent drainage from all 5 dental implant sites with submental and submandibular space infections 2 weeks after surgery. Treatment consisted of extraoral incision and drainage of involved fascial spaces, removal of all ...
Adalimumab (Humira , AbbVie Inc, USA) is EMA approved for children ages ≥4 years with severe plaque-psoriasis.
To evaluate the efficacy and safety of CT-P10, a rituximab biosimilar after a single switch, during a multinational, randomized, double-blind Phase 3 trial involving patients with RA.
Infliximab is increasingly used to treat neurosarcoidosis. We aimed to determine the efficacy and tolerance of an infliximab biosimilar for treating neurosarcoidosis.
To evaluate the relationship between radiographic progression and disease activity in subjects with PsA treated with adalimumab (ADA) or placebo (PBO) and the impact of concomitant MTX.
Concerns and side effects of azathioprine during adalimumab induction and maintenance therapy for Japanese patients with Crohn's disease: a sub-analysis of a prospective randomized clinical trial (DIAMOND study).
Combining a thiopurine with the human anti-tumor necrosis factor- monoclonal antibody adalimumab for Crohn's disease (CD) treatment is controversial with regard to efficacy and safety. By conducting a sub-analysis of a multicenter, randomized, prospective, open-label trial (the DIAMOND study, UMIN registration number 000005146), we studied the risk of discontinuation of thiopurine in combination with adalimumab.
Psoriasis can adversely affect quality of life (QoL) and emotional well-being. In this UK prospective observational study we evaluated the 'real-world' impact of adalimumab on QoL and the physical/psychological effects of moderate-to-severe psoriasis. 143 biologic-naïve patients with moderate-to-severe psoriasis, receiving adalimumab in clinical practice, were included. Patients completed a series of questionnaires at baseline (adalimumab initiation), 4 and 16-weeks and 6-months post-adalimumab initiation ...