Biosimilar Drugs for Multiple Sclerosis: An Unmet International Need or a Regulatory Risk?

AbstractMultiple sclerosis (MS) more than any other neurological disorder has experienced a tremendous progress in available evidence-based innovator disease modifying therapies (DMT). These medications include injectable complex nonbiological drugs (CNBD), the injectable biological products β-interferons-1a and -1b, and the infusible monoclonal antibodies (MAB), as well as oral synthetic therapeutic molecules. The degree of efficacy and adverse effects profile is variable. By the end of 2019, all medications have been approved for relapsing forms of MS, including five with indication for clinically isolated syndrome (CIS), two for active secondary progressive MS, and one for primary progressive MS. With the advent of the first generation or “platform” injectable DMT in the 1990s the cost of MS care increased substantially driven basically by the cost of these therapies. As n ew drugs licensed by health agencies appeared in the global market, the cost of these agents notably increased augmenting the economic gravamen of disease particularly in North America This industrial phenomenon has been promoted by the remarkable profits obtained by the biopharmaceutical companies producing these medications, costs increasing about seven times per patient per year in the span of two decades. The global MS drug market was valued at US$16.3 billion in 2016, expecting to reach US$27.8 billion by 2025. The societal and economic effect of these costs constitute an internatio...
Source: Neurology and Therapy - Category: Neurology Source Type: research

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Following publication the authors informed the Journal that  the published version of this article contained a mistake. All occurrences of pg/μl found in the original article should be changed to pg/L. The original article has been corrected. The correction has no impact on the conclusions drawn in the manuscript.
Source: Neurological Sciences - Category: Neurology Source Type: research
Multiple sclerosis often leads to fatigue and changes in physical behavior (PB). Changes in PB are often assumed as a consequence of fatigue, but effects of interventions that aim to reduce fatigue by improvin...
Source: Journal of NeuroEngineering and Rehabilitation - Category: Rehabilitation Authors: Tags: Research Source Type: research
AbstractGadolinium-based contrast agents (GBCAs) increase lesion detection and improve disease characterization for many cerebral pathologies investigated with MRI. These agents, introduced in the late 1980s, are in wide use today. However, some non-ionic linear GBCAs have been associated with the development of nephrogenic systemic fibrosis in patients with kidney failure. Gadolinium deposition has also been found in deep brain structures, although it is of unclear clinical relevance. Hence, new guidelines from the International Society for Magnetic Resonance in Medicine advocate cautious use of GBCA in clinical and resea...
Source: Insights into Imaging - Category: Radiology Source Type: research
CONCLUSIONS AND CLINICAL IMPLICATIONS: Dry mouth and bleeding from gums are more frequent in patients with longer lasting and more advanced types of MS. Daily oral hygiene and oral health self-control is limited in patients with MS, mainly due to motor deficits, balance problems and pain, and this becomes worse with disease duration. To minimise the burden of the disease, patients with MS require better education and improvement in their awareness regarding proper oral health control, such as the use of electric toothbrushes. In addition, patients with chronic and progressive disability from multiple sclerosis may benefit ...
Source: Neurologia i Neurochirurgia Polska - Category: Neurology Authors: Tags: Neurol Neurochir Pol Source Type: research
Abstract Neurodegenerative diseases are progressive and uncontrolled gradual loss of motor neurons function or death of neuron cells in the central nervous system (CNS) and the mechanisms underlying their progressive nature remain elusive. There is urgent need to investigate therapeutic strategies and novel treatments for neural regeneration in disorders like Alzheimer's disease (AD), Parkinson's disease (PD), amyotrophic lateral sclerosis (ALS), and multiple sclerosis (MS). Currently, the development and identification of pluripotent stem cells enabling the acquisition of a large number of neural cells ...
Source: Current Stem Cell Research and Therapy - Category: Stem Cells Authors: Tags: Curr Stem Cell Res Ther Source Type: research
ConclusionsThe base-case analysis shows that treatment of RRMS with cladribine tablets is cost effective versus alemtuzumab and fingolimod in HDA patients, and cost effective versus natalizumab in RES patients, at a threshold of €50,000. Driven by the lower costs, cladribine tablets were cost effective (dominant) in all base-case analyses. However, given that outcomes are based on indirect comparisons and post hoc subgroup analysis, as well as the uncertainty surrounding the outcomes, the results presented in this paper s hould be interpreted with caution.
Source: Applied Health Economics and Health Policy - Category: Health Management Source Type: research
Multiple Sclerosis (MS) is a neurodegenerative disease associated with cognition and balance impairments, which can lead to accidental falls. Postural control requires cognitive resources. This interaction is quantifiable by using the dual-task paradigm. The cognitive-postural interference (CPI) is commonly evaluated through an assessment of the dual-task cost (DTC). However, heterogeneous methodology for the assessment of DTC creates ambiguity and complicates comparison of results documenting a CPI. The aim of this review was to summarise literature related to process, results and effects of CPI in MS patients. The Pris...
Source: Frontiers in Neurology - Category: Neurology Source Type: research
Tracking sNfL levels over time corresponds to multiple sclerosis disease course in a longitudinal study, but use of the blood biomarker for individual prognosis remains unclear.Medscape Medical News
Source: Medscape Neurology and Neurosurgery Headlines - Category: Neurology Tags: Neurology & Neurosurgery News Source Type: news
Authors: Chisari CG, Toscano S, D'Amico E, Lo Fermo S, Zanghì A, Arena S, Zappia M, Patti F Abstract Introduction: In the last 20 years the armamentarium for multiple sclerosis (MS) treatment has been enriched from an increasingly wider variety of new drugs in order to reach a better control of the disease with a better patient compliance. Areas covered: With this great variety of therapeutic options, physicians may face new and major challenges. The huge amount of data from pilot studies and real-life settings showed that the first line therapies have a better safety profile. On the other hand, the risks as...
Source: Expert Opinion on Drug Safety - Category: Drugs & Pharmacology Tags: Expert Opin Drug Saf Source Type: research
European researchers have identified a visual sign on 3-tesla MR images that...Read more on AuntMinnie.comRelated Reading: 7T MRI and 3D printing uncover signs of severe MS 7T MRI shows path to MS progression Contrast not needed for follow-up MRI on MS patients MRI shows drug slows brain atrophy in MS patients MRI links iron in the brain to multiple sclerosis
Source: AuntMinnie.com Headlines - Category: Radiology Source Type: news
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