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PubMed Journals Articles About "Approves First Biosimilar Roche Cancer Drug Rituxan Https" RSS

18:04 EDT 15th September 2019 | BioPortfolio

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Showing "approves first biosimilar Roche cancer drug Rituxan https" PubMed Articles 1–25 of 24,000+

The effects of message framing on patients' perceptions and willingness to change to a biosimilar in a hypothetical drug switch.

Patients may hold negative perceptions towards biosimilars which can create barriers to their uptake. Physicians also report uncertainty in how best to explain biosimilars. The aim of this study was to measure the effect of differently framed explanations on patients' perceptions of and willingness to change to a biosimilar in a hypothetical drug switch.


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...

Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer.

We assessed long-term cardiac safety and efficacy in patients with human epidermal growth factor receptor 2-positive early breast cancer treated with a trastuzumab biosimilar (SB3) or its reference product, trastuzumab (TRZ), in a phase 3 study.


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.

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.

Retention rate and long-term safety of biosimilar CT-P13 in patients with ankylosing spondylitis: data from the Korean College of Rheumatology Biologics registry.

To evaluate the long-term drug retention, efficacy, and safety of the infliximab biosimilar CT-P13 in Korean patients with ankylosing spondylitis (AS) in clinical practice. The primary outcome was drug retention (i.e. time to treatment discontinuation or changing to another biologic) in Korean patients with AS. Additional outcomes included efficacy and safety.

Physicochemical and functional assessments demonstrating analytical similarity between rituximab biosimilar HLX01 and the MabThera®.

Development of bio-therapeutics has exhibited exponential growth in China over the past decade. However, no biosimilar drug has been approved in China (CN) due to the lack of a national biosimilar regulatory guidance. HLX01, a rituximab biosimilar developed in China under European Medicines Agency biosimilar guidelines and requirements, was the first such drug submitted for regulatory review in China, and it is expected to receive approval there as a biosimilar product. To demonstrate the analytical similar...

Rapid Characterization of Structural and Functional Similarity for a Candidate Bevacizumab (Avastin) Biosimilar using a Multipronged Mass Spectrometry-Based Approach.

The ongoing shift from small molecule drugs to protein therapeutics in the pharmaceuticals industry presents a considerable challenge to 'generic' drug developers who are increasingly required to demonstrate biosimilarity for biological macromolecules; a task that is decidedly more complex than doing the same for small molecule drugs. In this work, we demonstrate a multipronged mass spectrometry-based workflow that allows rapid and facile molecular characterization of antibody-based protein therapeutics, ap...

Evaluating Efficacy, Safety, and Pharmacokinetics After Switching From Infliximab Originator to Biosimilar CT-P13: Experience From a Large Tertiary Referral Center.

The use of infliximab biosimilar CT-P13 has increased in patients with inflammatory bowel disease. Nevertheless, doubts about switching from infliximab originator to biosimilar still exist among patients and health care professionals.

Real-Life Tolerability and Effectiveness of Adalimumab Biosimilar in Rheumatoid Arthritis: ASPIRE Registry Data.

The TNF-α blocker adalimumab is a well-proven therapy for rheumatoid arthritis (RA). A biosimilar adalimumab (ZRC-3197; Exemptia™), a 'fingerprint match' to reference adalimumab, has been approved for prescription in India since 2014. Here, we report on the effectiveness and tolerability of this biosimilar adalimumab (bADA) from the Adalimumab Biosimilar Patient Registry [ASPIRE; ISRCTN16838474], which contains data from real-life RA patients from India.

Rising Cancer Drug Prices: What Can Low- and Middle-income Countries Do?

Public health systems face the contradiction of skyrocketing cancer incidence and cancer drug prices, thus limiting patient access to more effective treatments. The situation is particularly dire in low- and middle-income countries. We urgently need consensus on the main determinants of this problem, as well as specific, effective and feasible solutions. Analysis of available data reveals that the problem has reached its current magnitude only recently and is not related to the growing complexity of drug pr...

Budget Impact of Switching to Biosimilar Trastuzumab (CT-P6) for the Treatment of Breast Cancer and Gastric Cancer in 28 European Countries.

As the economic burden of treating cancer patients has been soaring in European countries, performing a budget impact analysis is becoming one of the requirements for payers' application dossiers.

Discovery of Noncancer Drug Effects on Survival in Electronic Health Records of Patients With Cancer: A New Paradigm for Drug Repurposing.

Drug development is becoming increasingly expensive and time consuming. Drug repurposing is one potential solution to accelerate drug discovery. However, limited research exists on the use of electronic health record (EHR) data for drug repurposing, and most published studies have been conducted in a hypothesis-driven manner that requires a predefined hypothesis about drugs and new indications. Whether EHRs can be used to detect drug repurposing signals is not clear. We want to demonstrate the feasibility o...

ANNALS EXPRESS: Multicenter evaluation of the Roche Elecsys® Active B12 (holotranscobalamin) electro-chemiluminesence immunoassay.

Background Vitamin B12 deficiency is a common disorder. In circulation, vitamin B12 is bound to transcobalamin (holotranscobalamin), which is considered the active form of cobalamin. The objective of this study was to evaluate the analytical performance of the Roche Elecsys Active B12 immunoassay. Methods Limit of quantification and linearity were assessed according to CLSI EP17-A2 and EP-6A guidelines. Precision and bias of Roche Active B12 test against Architect ci8200 (Abbott) were performed according to...

Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study.

Real-world data on the comparative effectiveness and safety of switching among different epoetins (including originators and biosimilars) are limited. In light of current debate about interchangeability, prescribers, some patient groups and decision makers are calling for additional post-marketing evidence on the clinical effects of switching between originator and biosimilar epoetins in chronic kidney disease (CKD) patients.

Potential drug-drug interactions and risk of unplanned hospitalization in older patients with cancer: A survey of the prospective ELCAPA (ELderly CAncer PAtients) cohort.

Because of comorbidities and polypharmacy, older patients with cancer have a greater risk of iatrogenic events. We aimed to characterize potential drug-drug interactions (PDIs) and the risk of unplanned hospitalization in older patients with cancer treated with antineoplastic agents (ANAs).

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.

Are we ready to close the discussion on the interchangeability of biosimilars?

Since the introduction of the first biosimilar the discussion about their interchangeability has persisted. The body of evidence gathered for biosimilars provides reassurance that they are approved based on a rigorous comparability exercise and do not show clinically meaningful differences to their reference products. There are no data suggesting that the risk of switching to a biosimilar in terms of increased immunogenicity is greater than switching between two batches of any biologic. The key concern arou...

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...

Cancer Drug Use in the Last Month of Life in Men With Castration-Resistant Prostate Cancer.

Several new drug therapies have been approved in CRPC in the past decade. However, little is known about their potential overuse at the end of life. Cancer therapy use at the end of life has been considered an indicator of overtreatment. The study objective was to describe CRPC drug use in the last month of life of CRPC patients in Quebec.

An update on the animal studies conducted for biosimilar approvals - Regulatory requirement vs actual scenario.

Nonclinical animal studies are considered as an integral part of biosimilar development program to demonstrate similarity and safety. We have compiled, reviewed and summarized animal studies conducted for European Medicines Agency (EMA) and United States Food and Drug Administration (US FDA) submission from 2006 till December 2018. The commonest animal studies conducted included repeat-dose toxicity study along with toxicokinetic, local tolerance and immunogenicity assessments, while the least common includ...

Lymphatic changes in cancer and drug delivery to the lymphatics in solid tumors.

Although many solid tumors use the lymphatic system to metastasize, there are few treatment options that directly target cancer present in the lymphatic system, and those that do are highly invasive, uncomfortable, and/or have limitations. This review gives a brief overview of lymphatic function and anatomy, discusses changes that befall the lymphatics in cancer and the mechanisms by which these changes occur, and presents limitations for drug delivery to the lymphatic system. We then go on to summarize rel...

Part 2: Physicochemical characterization of bevacizumab in 2 mg/mL antibody solutions as used in human i.v. administration: Comparison of originator with a biosimilar candidate.

The physicochemical properties of Avastin® manufactured in the USA (Originator USA) and in Europe (Originator EU) and ABX-BEV, a bevacizumab biosimilar drug product candidate produced by Apobiologix Inc., were characterized at a clinically relevant concentration of 2 mg/mL following dilution of the 25 mg/mL drug products with 0.9% NaCl. Measurements using 14 orthogonal analytical methods performed within 5 h after dilution showed good similarity of the three antibodies as regards secondary structure,...

MiR-204 inhibits hepatocellular cancer drug resistance and metastasis through targeting NUAK1.

Liver cancer is a leading cause of cancer-related deaths globally. Tumor response rate of liver cancer patients towards systemic chemotherapy is low and chemoresistance can easily develop. Identifying novel molecules that can repress drug resistance and metastasis of liver cancer will facilitate the development of new therapeutic strategies. The aim of this study is to determine the roles of NUAK1 and miR-204 in the drug resistance and metastasis of liver cancer and to reveal their relationship. We found th...

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.


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