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03:46 EDT 6th April 2020 | BioPortfolio

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Showing "Alvotech JAMP Partner Canadian Biosimilars" PubMed Articles 1–25 of 1,400+

Real-World Budget Impact of Listing a Biosimilar of Rituximab.

The approval of new biosimilars by national health agencies is expected to generate significant cost savings for health care systems. This is particularly the case with the biosimilar of rituximab approved for the Canadian market in 2019. However, several uncertainties remain regarding utilization of this agent.

Powerful rare variant association testing in a copula-based joint analysis of multiple phenotypes.

In genetic association studies of rare variants, the low power of association tests is one of the main challenges. In this study, we propose a new single-marker association test called C-JAMP (Copula-based Joint Analysis of Multiple Phenotypes), which is based on a joint model of multiple phenotypes given genetic markers and other covariates. We evaluated its performance and compared its empirical type I error and power with existing univariate and multivariate single-marker and multi-marker rare-variant te...

Lessons from International Experience with Biosimilar Implementation: An Application of the Diffusion of Innovations Model.

Although biosimilars offer cost savings in Canadian healthcare, uptake is low. We discuss the literature on international experiences with biosimilar adoption in the context of the Diffusion of Innovations model. We highlight potential challenges with biosimilar implementation and gaps in research needed to inform implementation efforts. We observe a lack of systematic description of implementation design and evaluation and a paucity of in-depth and engaged research to understand stakeholders' pragmatic con...

Biosimilars in developed economies: Overview, status, and regulatory considerations.

Biotherapeutics dominate the pipelines of pharmaceutical companies across the world today with products ranging from hormones, immune-modulators, monoclonal antibodies (mAbs), blood coagulation factors, enzymes and vaccines. However, they are considerably more expensive than their small molecule counterparts (pharmaceuticals) and as a result their contribution to the already unacceptably high healthcare costs in the developed economies (Europe, United States, Japan, Canada and South Korea) has been in the l...

An In Vitro comparison of four different immunoassays for the monitoring of Infliximab biosimilars drug levels.

SB2 (Renflexis®, Merck) and CT-P13 (Inflectra®, Pfizer) are biosimilars of the reference Infliximab (Remicade®, Janssen) and are approved in Canada for use in indications for which Infliximab is approved, including inflammatory bowel disease. These biosimilars are structurally different but exhibit comparable physicochemical characteristics, pharmaceutical effectiveness and immunogenicity compared to Infliximab. Optimal Infliximab therapy currently relies on therapeutic drug monitoring offered by several...

The Era of Therapeutic Biosimilars Has Arrived: What You Need to Know.

Although complex, biologic agents are key components of modern therapy in multiple disciplines, particularly oncology. However, despite the fact that biosimilars (eg, filgrastim-sndz, bevacizumab-awwb, trastuzumab-dkst, rituximab-abbs) have been approved in the United States, many clinicians are poorly informed about their unique pathway for approval. At the NCCN 2019 Annual Congress: Hematologic Malignancies, Dr. Andrew D. Zelenetz, Memorial Sloan Kettering Cancer Center, outlined important issues regardin...

Biosimilars in Rheumatology.

Biotechnologicals are an invaluable resource in the treatment of patients with inflammatory rheumatic diseases (IRD) non-responsive or intolerant to conventional therapies. However, they are the main driver for increase in direct costs and represent a significant economic burden to healthcare systems worldwide. Since biosimilars are similar and more affordable versions of previously licenced biotechnologicals, they are expected to contribute to healthcare system sustainability and reduce inequities in treat...

Delivering on the Promise of Biosimilars.

Fifteen years of experience with biosimilar evaluation in Europe and advancement in the science behind biological medicines, provides a timely moment to open up debate as to whether the requirements for biosimilar approval could be further tailored. Further optimizing of data requirements to truly decisional information will allow to continuously deliver on the promise of biosimilars, providing benefits for patients and society.

Biosimilars vs originators: Are they the same?

Biological drugs have revolutionised the treatment of rheumatic diseases, and the recent expiry of the patents for many biological agents has generated considerable interest among pharmaceutical companies and regulatory agencies, and led to the marketing of highly similar, low-cost versions known as biosimilars. The increasing trend of switching patients from effective but expensive drugs to their biosimilar counterparts will have a considerable economic impact in the coming years. However, although this wi...

Breakdown in the Expedited Partner Therapy Treatment Cascade: From Reproductive Healthcare Provider to the Pharmacist.

The rising incidence rates of sexually transmitted infections (STI) in the U.S. highlight the need for concurrent treatment of patients and their sexual partners. Expedited partner therapy (EPT) allows healthcare providers to offer antibiotic prescriptions or medications to an index patient for distribution to their sexual partner(s) without evaluating the partner. We hypothesized that there was a gap between EPT policy at the state level and its downstream implementation by community pharmacists.

Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars.

Biosimilars must meet stringent regulatory requirements, both at the time of authorization and during their lifecycle. Yet it has been suggested that divergence in quality attributes over time may lead to clinically meaningful differences between two versions of a biologic. Therefore, this study investigated the batch-to-batch consistency across a range of parameters for released batches of the etanercept biosimilar (SB4) and infliximab biosimilar (SB2).

A new Canadian inception cohort for juvenile idiopathic arthritis: The Canadian Alliance of Pediatric Rheumatology Investigators Registry.

The aim was to describe the design, methods and initial findings of a new Canadian inception cohort of children with JIA, The Canadian Alliance of Pediatric Rheumatology Investigators (CAPRI) JIA Registry.

2019 Canadian Urological Association (CUA)-Canadian Uro Oncology Group (CUOG) guideline: Management of castration-resistant prostate cancer (CRPC).

Are Biosimilars the Future of Oncology and Haematology?

Biological drugs are vital but often high-cost components of cancer treatment. Several biosimilar versions of these drugs have been approved in Europe and/or the USA, with many more in development. However, there is some disconnect between the biosimilars that are approved for use and those accessible in clinical practice, with availability impacted by factors including patent litigation and complex healthcare insurance policies, particularly in the USA. Provided the barriers to widespread uptake can be ove...

Factors associated with condom use during sexual intercourse with a new partner among Scandinavian women.

In this population-based, cross-sectional questionnaire study among 18-45-year-old women from Denmark, Sweden, and Norway conducted during 2011-2012 we examine factors associated with using condoms with a new partner. Condom use with a new partner was assessed among 6202 women having had a new partner in the recent six months. Odds ratios (OR) and 95% confidence intervals (CI) were estimated for the associations between sociodemographic and lifestyle factors, and sexual behavior, respectively, and condom us...

A Canadian strategy for surgical quality improvement

The Canadian Association of General Surgeons (CAGS) Board of Directors hosted a symposium to develop a Canadian strategy for surgical quality and safety at its mid-term meeting on Feb. 24, 2018. The following 6 principles outline the consensus of this symposium, which included diverse stakeholders and surgeon leaders across Canada: 1) a Canadian quality-improvement strategy for surgery is needed; 2) quality improvement requires continuous, active and intentional effort; 3) outcome measurement alone will not...

Disease Modelling and Precision Medicine Using Canadian Cardiomyocytes.

Concordance of self- and partner-reported alcohol consumption among couples experiencing intimate partner violence in Zambia.

Hazardous alcohol use is a predictor of intimate partner violence (IPV) and both are increasingly prevalent in sub-Saharan Africa. The accurate measurement of alcohol consumption is therefore critical in IPV intervention studies that target hazardous drinking. Collecting a collateral report in addition to self-report is one convergent validity approach to improve alcohol measurement. We investigated concordance between self- and partner-reported alcohol use among women who reported recent IPV and their male...

Canadian Urological Association-Canadian Urologic Oncology Group guideline on metastatic castration-naive and castration-sensitive prostate cancer.

Perceived neighborhood disorder and psychological distress among Latino adults in the United States: Considering spousal/partner relationship.

It has been well-established that neighborhood disorder and disadvantage are detrimental to mental health and psychological well-being. There has been growing research interest in minority stress issues, however, less is known about how perceived neighborhood disorder matters for psychological well-being among Latino adults in the United States. Analyzing data from National Latino Asian American Study, 2002-2003, the present study investigates the relationships among perceived neighborhood disorder, spousal...

Factors Associated With Human Immunodeficiency Virus Infections Linked in Genetic Clusters But Disconnected in Partner Tracing.

Successful partner notification can improve community-level outcomes by increasing the proportion of persons living with human immunodeficiency virus (HIV) who are linked to HIV care and virally suppressed, but it is resource intensive. Understanding where HIV transmission pathways may be undetected by routine partner notification may help improve case finding strategies.

Persistence of partner-assisted skin self-examination supported by "being in this together": a randomized trial.

Since approximately 12% of melanoma survivors will develop another melanoma, skin self-examination (SSE) is relevant. Structured SSE training with a partner may overcome challenges including a) motivation to undertake SSE; b) competence to recognize concerning lesions, and c) difficulty with long-term maintenance (≥1 year). Partner-assisted SSE and subsequent clinical presentation to a dermatologist for concerning moles rely on self-management, adoption of decision rules, and taking appropriate action.

The Scent of a Good Night's Sleep: Olfactory Cues of a Romantic Partner Improve Sleep Efficiency.

Almost nothing is known about whether exposure to the scent of loved ones influences sleep. In the current study, 155 participants spent 2 nights with their partner's scent and 2 nights with a control scent (in random order). Sleep was measured in two ways: sleep efficiency (via actigraphy) and perceived sleep quality (via self-report). Sleep efficiency was higher when participants were exposed to their partner's scent. This increase occurred regardless of participants' beliefs about the origin of the scent...

Towards a comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars in treating chemotherapy associated febrile neutropenia: Trends from decades of data.

Filgrastim, a biopharmaceutical listed on WHO model list of essential medicines, was approved in USA in 1991 for patients with non-myeloid malignancies associated with severe neutropenia and fever. Several filgrastim biosimilars have now been approved in USA, Europe and elsewhere since 2008, based on the reference product which has lost patent exclusivity; however their immunogenicity and safety is controversial. We conducted a retrospective, post market study between 1991 and May 2018 using VigiBase®. The...

Ambulatory Blood Pressure Response to Romantic Partner Interactions and Long-Term Cardiovascular Health Outcomes.

Lower BP during romantic partner interactions may underlie the association between romantic relationships and better long-term cardiovascular health.This secondary analysis examined the effect of momentary ABP response to partner interactions on between-person changes in LVMI and mean systolic and diastolic BP over time.

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