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

05:20 EST 12th December 2017 | BioPortfolio

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Showing "CHMP First Biosimilar Herceptin Another Version Humira" PubMed Articles 1–25 of 1,100+

Biosimilar registered despite the Netherlands opposing vote: greater uncertainty about authorised drugs in the Netherlands.

On 1 April 2016 the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on a new biological medicine, Flixabi®, a biosimilar to infliximab (Remicade®); however, in the appendix of the European Public Assessment Report (EPAR) it appeared that an important minority (14 of 33 votes) opposed this decision, among them the Netherlands representative. In an original article, the Dutch Medicines Board (CBG-MEB) explained the reason for this decision, but still allowed the drug on the m...


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...

Biosimilar monoclonal antibodies (mAbs) in oncology.

Biological medicines are derived from living cells and organisms. Monoclonal antibodies (mAbs) are biological agents that are widely used to treat malignancies including non-Hodgkin's lymphomas and chronic lymphocytic leukaemia. They are effective but expensive. The patents for many mAbs are expiring, so biosimilar medicines, which contain a version of the active ingredient of the original drug, are being developed. Biological medicines cannot be assessed in the same way as standard generic medications beca...


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.

The Biosimilar Pipeline Seams Seem To Be Bursting.

The biosimilar segment of the pharmaceutical industry is on fire. Some 700 biosimilars are at some stage of development, and more than 660 companies are involved in some way in the biosimilars land rush. Still, only a handful may get on the market in the next few years.

Biosimilar Makers Hope Court Starts 6-Month Wait Sooner.

The dispute centers on dueling interpretations of the Biologics Price Competition and Innovation Act, which says a company seeking to sell a biosimilar must give the maker of the brand-name biologic at least a 180-day notice before selling its drug.

Evolution after switching to biosimilar infliximab in inflammatory bowel disease patients in clinical remission.

The biosimilar of infliximab (CT-P13) has been approved for the same indications held by the infliximab reference product (Remicade(®)); however, there are few clinical data on switching in inflammatory bowel disease (IBD). The aim of this study was to assess the efficacy, safety, bioavailability profile and factors associated with relapse after switching to biosimilar infliximab in IBD patients in clinical remission.

Clinical Similarity of the Biosimilar ABP 501 Compared With Adalimumab After Single Transition: Long-Term Results From a Randomised, Double-Blind, 52-Week, Phase 3 Study in Moderate-to-Severe Plaque Psoriasis Patients.

ABP 501, an FDA- and EMA-approved biosimilar, is highly similar to adalimumab in structure, function, and pharmacokinetics.

Biosimilars: Implications for Clinical Practice.

In 2015, the United States Food and Drug Administration (FDA) approved the first biosimilar, filgrastim-sndz, a biosimilar of the granulocyte colony-stimulating factor filgrastim. Since that time, the FDA has approved four additional biosimilar tumor necrosis factor α inhibitors, and, in May 2017, the Oncology Drug Advisory Committee voted in favor of approval of an epoetin alfa biosimilar. The patents of several widely used biologic cancer therapies (including trastuzumab, rituximab, bevacizumab, cetuxima...

A phase I, randomized, single-dose study evaluating the pharmacokinetic equivalence of biosimilar ABP 215 and bevacizumab in healthy adult men.

This study compared the pharmacokinetic (PK) profiles of the proposed biosimilar ABP 215 with bevacizumab in healthy males.

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...

FDA Guidance on Biosimilar Interchangeability Elicits Diverse Views: Current and Potential Marketers Complain About Too-High Hurdles.

Pharmaceutical industry sectors are at odds as the Food and Drug Administration seeks to define "interchangeability" for biosimilars. The battle lines vary by topic, but biosimilar marketers, health plans, and drugstores are generally urging lower hurdles.

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.

Biosimilar G-CSF versus filgrastim and lenograstim in healthy unrelated volunteer hematopoietic stem cell donors.

The World Marrow Donor Organization recommends original granulocyte-colony stimulating factor (G-CSF) for the mobilization of stem cells in healthy unrelated hematopoietic stem cell donors. We report the comparison of a biosimilar G-CSF (Zarzio) with two original G-CSFs (filgrastim and lenograstim) in mobilization in unrelated donors. We included data of 313 consecutive donors who were mobilized during the period from October 2014 to March 2016 at the Medical University of Warsaw. The primary endpoints of t...

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.

Comparison of morning basal + 1 bolus insulin therapy (insulin glulisine + insulin glargine 300 U/ml vs. insulin lispro + insulin glargine biosimilar) using continuous glucose monitoring (CGM): a randomized crossover study.

We compared the effects of morning administration of insulin glulisine + insulin glargine 300 U/ml (G+G300) to that of insulin lispro + insulin glargine biosimilar (L+GB).

A Survey Assessment of US Dermatologists' Perception of Biosimilars.

BACKGROUND: Biologics have transformed the treatment of psoriasis and psoriatic arthritis, but at a significant cost to payers and patients. The introduction of biosimilars into the US market could reduce costs while increasing access to biologic medications. OBJECTIVE: We sought to identify gaps in biosimilar knowledge and perception among US dermatologists. METHODS: An online survey was sent to dermatologists from January to April 2015. RESULTS: Ninety-seven US dermatologists responded, of which 84% state...

Biosimilars in Oncology in the United States: A Review.

Biosimilars are biological medicines that contain a highly similar version of the active substance of an already approved biologic reference product. The availability of biosimilars might provide an opportunity to lower health care expenditures as a result of the inherent price competition with their reference product. Understanding how biosimilar cancer drugs are regulated, approved, and paid for, as well as their impact in a value-based care environment, is essential for physicians and other stakeholders ...

Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab After One Year in a Prospective Nationwide Cohort.

It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort.

Infliximab biosimilar CT-P13 in the treatment of chronic plaque psoriasis. Data from the Psobiosimilars registry.

Infliximab is a chimeric human-murine monoclonal antibody that is very effective in chronic plaque psoriasis reaching a Psoriasis Area and Severity Index (PASI) 75 response in 80.4% of patients at week 10.(1) The more common adverse events include infusion reactions and upper respiratory tract infections.(2) The European Medicines Agency has approved the use of infliximab biosimilar CT-P13 for psoriasis by extrapolating efficacy from studies in rheumatoid arthritis and ankylosing spondilytis.(3,4) This arti...

Challenges to Biosimilar Substitution.

Efficacy and safety of Biosimilar (SAR342434 insulin lispro) in adults with type 1 diabetes also using insulin glargine-SORELLA 1 study.

SAR342434 is a biosimilar (follow-on) of insulin lispro-Humalog®. This study aimed to show similar efficacy, safety and immunogenicity of SAR342434 (SAR-Lis) versus insulin lispro-Humalog (Ly-Lis) in adult patients with type 1 diabetes (T1DM) treated with multiple daily injections while using basal insulin glargine (Lantus®; GLA100GLA-100).

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...

Challenges to Biosimilar Substitution-Reply.

Comparison of Magnetic Resonance Imaging and Computed Tomography Scans of the Glenoid Version in Anterior Dislocation of the Shoulder.

The glenoid version is an important factor in the etiology of anterior dislocation of the shoulder and the planning of shoulder surgery. Few reports compare the magnetic resonance imaging (MRI) measurements of the glenoid version with those of computed tomography (CT). This study aimed to show that it is possible to use MRI instead of CT, which is accepted as the gold standard today for the evaluation of the glenoid version. A total of 55 patients with a history of 1 nonsurgically treated unilateral anterio...


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