Results 81 to 90 of about 5,547 (244)

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

Neurology and Therapy, 2019
Multiple sclerosis (MS) more than any other neurological disorder has experienced a tremendous progress in available evidence-based innovator disease modifying therapies (DMT).
Victor M. Rivera
doaj   +1 more source

Perceptions towards biologic and biosimilar therapy of patients with rheumatic and gastroenterological conditions

BMC Rheumatology, 2022
Background Biologic and targeted synthetic disease modifying agents (b/tsDMARDs) have broadened the treatment landscape for autoimmune diseases particularly in patients refractory to conventional DMARDs. More recently, the introduction of biosimilars has
Thomas Khoo, Navkiran Sidhu, Franca Marine, Susan Lester, Alannah Quinlivan, Debra Rowett, Rachelle Buchbinder, Catherine L. Hill   +7 more
doaj   +1 more source

Policy Networks and Policy Entrepreneurship in the EU: Explaining Structural Policy Change in Pharmaceutical Innovation Incentives and Health Technology Assessment

European Policy Analysis, EarlyView.
ABSTRACT Policy process research has excelled in explaining structural policy change within national settings, but extensions and applications to the EU level have long proven challenging for scholars. Given that the EU is currently experiencing its longest period of Treaty stability since the 1980s—having evolved into a sui generis political system ...
Vassilis Karokis‐Mavrikos
wiley   +1 more source

Incidence of serious infection among etanercept and infliximab initiators: safety comparison between biosimilars and bio-originators with Canadian population-based data

BMC Rheumatology
Background Safety remains a significant concern for biologic drugs, and studies are needed to ensure a comparable safety profile for biosimilars and their legacy treatments.
Marina G. Birck, Luck Lukusa, Denis Choquette, Gilles Boire, Walter P. Maksymowych, Harminder Singh, Waqqas Afif, Sasha Bernatsky   +7 more
doaj   +1 more source

Comparing the original and biosimilar biotherapeutics of the monoclonal antibody eculizumab by intact mass measurement and middle-up mass spectrometry analysis

Тонкие химические технологии, 2021
Objectives. In this biosimilar research, we compare the monoclonal antibody eculizumab obtained from different drugs [original Soliris® (Alexion Pharmaceuticals) and candidate Elizaria® (Generium)] by intact mass measurement and middle-up mass ...
M. B. Degterev, R. R. Shukurov
doaj   +1 more source

Regulation of Innovation Under Follow-On Biologics Legislation: FDA Exclusivity as an Efficient Incentive Mechanism [PDF]

, 2010
As part of its broader effort to reform the American health care system, Congress has recently enacted legislation that creates a statutory pathway for FDA approval of generic "follow-on" biologics products.
Morgan, Maxwell R.
core   +2 more sources

Development of a step‐gradient simulated moving bed process for the polishing of monoclonal antibodies with anion exchange chromatography

Journal of Chemical Technology &Biotechnology, EarlyView.
Abstract BACKGROUND In recent years, biopharmaceutical applications in medicine have seen explosive growth and the need for efficient, rapid and inexpensive purification of these targets is the topic of tremendous research and development. The need to improve process efficiency has been an active area of investigation due to the tremendous potential ...
Yasmina MJ Harsy, Jonas Wege, Anthony Grabski, Romain Dabre, Egbert Müller, Carsten‐René Arlt   +5 more
wiley   +1 more source

BIOSIMILARS IN RHEUMATOLOGY

Научно-практическая ревматология, 2017
One of the most striking achievements in the pharmacotherapy of rheumatoid arthritis (RA) and other human immunoinflammatory diseases (IIDs) late in the 20th century is associated with the design of a fundamentally new group of medications that received ...
E. L. Nasonov
doaj   +1 more source

Assessing attitudes, access, barriers, and facilitators to multidisciplinary care in pediatric inflammatory bowel disease

JPGN Reports, EarlyView.
Abstract Objective Multidisciplinary care is recommended for pediatric inflammatory bowel disease (IBD). This study aims to describe provider attitudes, barriers, and facilitators regarding multidisciplinary care in pediatric IBD, and explore associations between multidisciplinary care access and center‐level factors.
Nicole Davidson, Jennie G. David, Jennifer L. Dotson, Brendan Boyle, Ross M. Maltz, Hilary K. Michel, ImproveCareNow Pediatric IBD Learning Health System   +6 more
wiley   +1 more source

Administrative Databases and Diagnostic Therapeutic and Assistance Paths -PDTA- in the Monitoring Treatment of Rheumatoid Arthritis: The Experience of ATS Pavia

Pragmatic and Observational Research, 2023
Giacomo M Bruno,1,2 Maria Chiara Valentino,2 Alessandra Brunetti,3 Sergio Di Matteo,2 Ivan Begovic,2 Edoardo Croce,4 Garifallia Sakellariou,5 Serena Bugatti,6 Pietro Perotti,7 Silvia Vecchio,7 Simona Migliazza,7 Roberto Langella,8 Giorgio L Colombo1,2 ...
Bruno GM, Valentino MC, Brunetti A, Di Matteo S, Begovic I, Croce E, Sakellariou G, Bugatti S, Perotti P, Vecchio S, Migliazza S, Langella R, Colombo GL   +12 more
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