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05:55 EDT 16th June 2019 | BioPortfolio

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Showing "Adalimumab biosimilar Idacio launched Germany" PubMed Articles 1–25 of 1,600+

Differences in immunogenicity associated with non-product related variability: insights from two pharmacokinetic studies using GP2017, an adalimumab biosimilar.

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: An Adalimumab Biosimilar.

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 ...

Effectiveness and safety of adalimumab biosimilar in inflammatory bowel disease: A multicenter study.

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).

The transient production of anti-TNF-α antibody Adalimumab and a comparison of its characterization to the biosimilar Cinorra.

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...

Evaluation of Physicochemical and Biological Stability of 36-Months-Aged SB5 (Adalimumab Biosimilar) for 4 Weeks at Room Temperature.

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...

Physicochemical and Biological Characterization of RTXM83, a New Rituximab Biosimilar.

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.

Adalimumab Effectiveness Up to Six Years in Adalimumab-naïve Patients with Crohn's Disease: Results of the PYRAMID Registry.

PYRAMID was an international multicenter, noninterventional, postmarketing registry assessing long-term safety and effectiveness of adalimumab (Humira), as used in routine clinical practice.

Antidrug antibody detection for adalimumab depends on the type of assay used: an experimental approach to help clinicians interpret diagnostic data.

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.

Evaluation of Infliximab and Anti-infliximab LISA-TRACKER Immunoassays for the Therapeutic Drug Monitoring of SB2 Infliximab Biosimilar.

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).

Comparative Stability Studies of Different Infliximab and Biosimilar CT-P13 Clinical Solutions by Combined Use of Physicochemical Analytical Techniques and Enzyme-Linked Immunosorbent Assay (ELISA).

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.

Etanercept biosimilar SB4 in the treatment of plaque-type psoriasis and psoriatic arthritis: a single-center, observational, retrospective, real-life study.

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...

Detection of anti-adalimumab antibodies in a RA responsive cohort of patients using three different techniques.

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...

Outcomes of Patients With Inflammatory Bowel Diseases Switched from Maintenance Therapy with a Biosimilar to Remicade.

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.

A Randomized, Double-Blind Trial Comparing the Pharmacokinetics of CT-P16, a Candidate Bevacizumab Biosimilar, with its Reference Product in Healthy Adult Males.

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.

Review article: managing the adverse events caused by anti-TNF therapy in inflammatory bowel disease.

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...

Adalimumab efficacy for venous thrombosis in typical sites in Behçet's syndrome.

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.

New Biosimilar Approvals for Myeloid Growth Factors and Anemia.

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.

Production of monoclonal antibodies for measuring Avastin and its biosimilar by Sandwich ELISA.

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...

Adalimumab-Related Dental Implant Infection.

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 ...

Sustained Long-Term Efficacy and Safety of Adalimumab in Pediatric Patients with Severe Chronic Plaque Psoriasis from a Randomised, Double-Blind, Phase 3 Study.

Adalimumab (Humira , AbbVie Inc, USA) is EMA approved for children ages ≥4 years with severe plaque-psoriasis.

Efficacy and safety of switching from rituximab to biosimilar CT-P10 in rheumatoid arthritis: 72-week data from a randomized Phase 3 trial.

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 biosimilar for treating neurosarcoidosis: tolerance and efficacy in a retrospective study including switch from the originator and initiation of treatment.

Infliximab is increasingly used to treat neurosarcoidosis. We aimed to determine the efficacy and tolerance of an infliximab biosimilar for treating neurosarcoidosis.

Inhibition of radiographic progression in psoriatic arthritis by adalimumab independent of the control of clinical disease activity.

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.

The real world impact of adalimumab on quality of life and the physical and psychological effects of moderate-to-severe psoriasis: a UK prospective, multicenter, observational study.

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 ...

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