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PubMed Journals Articles About "CHMP First Biosimilar Herceptin Another Version Humira" RSS

22:54 EDT 23rd May 2018 | BioPortfolio

CHMP First Biosimilar Herceptin Another Version Humira PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest CHMP First Biosimilar Herceptin Another Version Humira articles that have been published worldwide.

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Showing "CHMP First Biosimilar Herceptin Another Version Humira" PubMed Articles 1–25 of 1,200+

Sandoz receives positive CHMP opinion for proposed biosimilar infliximab.


A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab.

Access to trastuzumab, a valuable anti-cancer treatment, can be limited by cost. The primary aim of this study was to evaluate and compare the PK profiles of CT-P6, a biosimilar of trastuzumab, and US-licensed reference trastuzumab (Herceptin®) in healthy subjects. Secondary study aims included comparison of the safety and immunogenicity of CT-P6 and reference trastuzumab in these subjects.

Glycosimilarity assessment of biotherapeutics 1: Quantitative comparison of the N-glycosylation of the innovator and a biosimilar version of etanercept.

The carbohydrate moieties on the polypeptide chains in most glycoprotein based biotherapeutics and their biosimilars play essential roles in such major mechanisms of actions as antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, anti-inflammatory functions and serum clearance. In addition, alteration in glycosylation may influence the safety and efficacy of the product. Glycosylation, therefore, is considered as one of the important critical quality attributes of glycoprotein b...


Switching to a infliximab biosimilar: short-term results of clinical monitoring in patients with inflammatory bowel disease.

Currently, a biosimilar of Remicade is available (CT-P13). Switching patients from Remicade to a biosimilar is still under debate, especially for patients with inflammatory bowel disease (IBD). In a retrospective study, we investigated the feasibility and safety of switching patients with IBD from Remicade to a biosimilar infliximab.

Subjective Complaints as Main Reason for Biosimilar Discontinuation after Open Label Transitioning from Originator to Biosimilar Infliximab.

To evaluate drug survival, effectiveness, pharmacokinetics, immunogenicity and safety after transitioning treatment from originator infliximab (Remicade(®) , REM) to biosimilar infliximab (CT-P13) in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis in daily practice.

Modulation of in vitro phagocytic uptake and immunogenicity potential of modified Herceptin®-conjugated PLGA-PEG nanoparticles for drug delivery.

There is an increasing interest in engineered nanoparticle (NP) conjugates for targeted and controlled drug delivery. However, the practical applications of these NP delivery vehicles remain constrained because of their reactivity with the body's immune system defenses resulting in undesirable off-target effects. In this study, poly(D,L lactide-co-glycolide) (PLGA)-b-polyethylene glycol (PEG) NPs conjugated to different quantities of the commercial antibody Herceptin® meant to target HER2-positive breast c...

Efficacy and safety of biosimilar insulins compared to their reference products: A systematic review.

For nearly a century, no generic form of insulin has been available in the United States. However, the first biosimilar insulin, Basaglar, was approved by the U.S. Food and Drug Administration in 2015, and subsequently Admelog and Lusduna in 2017.

Policies for biosimilar uptake in Europe: An overview.

Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe.

Antibodies as Carrier Molecules: Encapsulating Anti-Inflammatory Drugs Inside Herceptine.

The human epidermal growth factor receptor 2 (HER2) is over-expressed in about a third of breast cancer patients, with a strong involvement of cyclooxygenase-2 (COX-2) enzyme in the tumor progress. HER2 and COX-2 are consequently potential targets for inhibiting carcionogenesis. Herceptin (trastuzumab) is an antibody that partially blocks HER2 positive cancers at their initial stage. Unfortunately, the overall response rate to the single treatment with this antibody is still modest and, therefore, it needs ...

Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: a phase 3, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy.

In 2015, the biosimilar filgrastim EP2006 became the first biosimilar approved by the US Food and Drug Administration (FDA) for commercial use in the United States, marketed as Zarxio®. This phase 3 randomised, double-blind registration study in patients with breast cancer receiving (neo)adjuvant myelosuppressive chemotherapy (TAC; docetaxel+doxorubicin+cyclophosphamide) compares reference filgrastim, Neupogen®, with two groups receiving alternating treatment with reference and biosimilar every other cycl...

Biosimilar switching and related medical liability.

Unlike generics, biosimilars are similar, but not equivalent, to the reference biological medicinal product. Therefore, if a patient experiences an adverse event, or a loss of efficacy, when transitioned to a biosimilar, the distribution of medical liability will be different from the case of both the originator and generics. Moreover, the case of naïve patients is different from that of non-naïve patients. In the case of naïve patients, physicians make their choice from a range of medicinal products tha...

The effects of the Union International Contre Cancer / American Joint Committee on Cancer Tumour, Node, Metastasis system version 8 on staging of differentiated thyroid cancer: A comparison to version 7.

to assess the changes resulting from the changes from UICC/AJCC TNM version 7 to version 8 and to subsequently determine whether TNM version 8 is an improvement compared to previous iterations of the TNM system and other staging systems for differentiated thyroid cancer (DTC) with regard to prognostic power.

Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results.

SB2 is a biosimilar to the reference infliximab (INF). Similar efficacy, safety and immunogenicity between SB2 and INF up to 30 weeks were previously reported. This report investigates such clinical similarity up to 54 weeks, including structural joint damage.

Electronic Version of the EQ-5D Quality-of-Life Questionnaire: Adaptation to a Brazilian Population Sample.

To assess the measurement equivalence of the original paper version of an adapted tablet version of the EuroQol five-dimensional questionnaire (EQ-5D).

Open-Label Non-Mandatory Transitioning From Originator Etanercept to Biosimilar SB4: 6-Month Results From a Controlled Cohort Study.

To evaluate the effects of non-mandatory transitioning from originator etanercept (ENB) to biosimilar etanercept (SB4) on drug survival and effectiveness in a controlled cohort study of patients with an inflammatory rheumatic disease.

Long-term treatment with biosimilar epoetin-α (HX575) in hemodialysis patients with renal anemia: real-world effectiveness and safety in the MONITOR-CKD5 study
.

To assess real-world effectiveness and safety of intravenous (IV) HX575, a biosimilar epoetin-α, in hemodialysis (HD) patients.

Switching from an originator anti-TNF to a biosimilar in patients with inflammatory bowel disease: Can it be recommended? A systematic review.

To review the effectiveness and safety of switching from an originator anti-TNF (Remicade) to a biosimilar (CT-P13) in patients with inflammatory bowel disease (IBD).

Phosphorylation of intracellular signaling molecules in peripheral blood cells from psoriasis patients on originator or biosimilar infliximab.

Psoriasis vulgaris is a chronic, inflammatory skin disease characterized by a dysregulated immune response and it is associated with substantial systemic comorbidities. Biological drugs like tumor necrosis factor (TNF) inhibitors can ameliorate the disease but are expensive. Biosimilar drugs have the same amino acid sequence as the originator, but differences in manufacturing can affect biological activity, efficacy and tolerability.

International Physical Activity Questionnaire for Adolescents (IPAQ A): reliability of an Italian version.

Recently a new version of International Physical Activity Questionnaire was performed for adolescent (IPAQ-A), but an Italian version lacks yet. The aim of the study is to examine the test-retest reliability of an Italian version of short IPAQ-A.

Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 2 Diabetes, Also Using Insulin Glargine: SORELLA 2 Study.

SAR342434 (SAR-Lis) is a biosimilar (follow-on) of insulin lispro (U100; Humalog®; Ly-Lis). This study aimed to show similar efficacy, safety, and immunogenicity of SAR-Lis versus Ly-Lis in adult patients with type 2 diabetes mellitus (T2DM) treated with multiple daily injections, while using insulin glargine (GLA-100; Lantus®) as basal insulin.

An Extension Study of PF-05280586, a Potential Rituximab Biosimilar, versus Rituximab in Subjects with Active Rheumatoid Arthritis.

This extension study provided continued treatment to subjects with active rheumatoid arthritis who had participated for ≥16 weeks in a pharmacokinetic similarity study of PF-05280586 (potential rituximab biosimilar). Objectives were to evaluate overall pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of PF-05280586 after transition from a licensed rituximab product to PF-05280586, and followup of biomarker and efficacy assessments.

Challenges to Biosimilar Substitution.

Moxibustion for Cephalic Version of Breech Presentation.

Moxibustion, a form of traditional Chinese medicine (TCM), is the burning of the herb moxa (Folium Artemisiae argyi or mugwort) over acupuncture points. It is often used in China to facilitate cephalic version of breech presentation. This article reviews the history, philosophy, therapeutic use, possible mechanisms of action, and literature pertaining to its use for this indication. For moxibustion, moxa can be rolled into stick form, placed directly on the skin, or placed on an acupuncture needle and ignit...

MONITOR-GCSF DLBCL subanalysis: treatment patterns/outcomes with biosimilar filgrastim for chemotherapy-induced/febrile neutropenia prophylaxis.

MONITOR-GCSF DLBCL subanalysis: treatment patterns/outcomes with biosimilar filgrastim for chemotherapy-induced/febrile neutropenia prophylaxis OBJECTIVE: Prospective data on the use of granulocyte-colony stimulating factor (G-CSF) in non-Hodgkin's lymphoma and its aggressive subtypes, including diffuse large B-cell lymphoma (DLBCL) are limited. MONITOR-GCSF is a pan-European, multicenter, prospective, observational study aiming to describe treatment patterns and clinical outcomes in patients receiving bios...

Biosimilar Substitution Laws.


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