Results 81 to 90 of about 790,096 (261)

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

Real-Life Clinical Effectiveness of Razumab® (the World’s First Biosimilar of Ranibizumab) in Retinal Vein Occlusion: A Subgroup Analysis of the Pooled Retrospective RE-ENACT Study

Ophthalmologica, 2018
Background: This subgroup analysis of the RE-ENACT study evaluates the effectiveness of Razumab® (the world’s first biosimilar of ranibizumab by Intas Pharmaceuticals Ltd.) in Indian patients with retinal vein occlusion (RVO).
Shashikant Sharma, M. Khan, A. Chaturvedi   +2 more
semanticscholar   +1 more source

Measuring the Outcomes of International Oncology Regulatory Collaboration in Canada from 2019 to 2025: Project Orbis

Clinical Pharmacology &Therapeutics, EarlyView.
Project Orbis, launched by the US FDA in 2019, enables collaboration among international regulatory agencies on cancer drug reviews. We assessed the regulatory impact of Project Orbis in Canada by analyzing publicly available data on marketing authorization applications (MAAs).
Jonathan Zaslavsky, David C. Sealey
wiley   +1 more source

Proactive therapeutic drug monitoring of infliximab leads to treatment durability in paediatric Crohn's disease: A single‐centre Australian experience

JPGN Reports, EarlyView.
Abstract Objectives To evaluate the durability and predictors of loss of response of infliximab (IFX) over 2 years in paediatric Crohn's disease (CD) utilizing a proactive therapeutic drug monitoring (TDM) strategy. Methods A retrospective, single‐centre cohort study was conducted at The Children's Hospital at Westmead (CHW), Australia, from January ...
Cher Wei Chuah, Jessica Eldredge, Annabel Magoffin, Edward Vincent O'Loughlin, Calvin Joomann Park, Juliana Puppi, Susan Siew, Michael Stormon, Kunal Thacker, Shoma Dutt   +9 more
wiley   +1 more source

Evaluation of Methods Employed in Establishing Preclinical Similarity of Adalimumab Biosimilars

Advances in Pharmacological and Pharmaceutical Sciences
Adalimumab, marketed as Humira, is a fully humanized monoclonal antibody that blocks the activity of tumor necrosis factor-alpha and is used in treating several autoimmune disorders. As one of the top-grossing pharmaceuticals, its global sales surpassed $
Ramya Nair, Naveen Krishnan, Vasudev Shenoy, Raviraja N. Seetharam   +3 more
doaj   +1 more source

Structural and In Vitro Functional Comparability Analysis of Altebrel™, a Proposed Etanercept Biosimilar: Focus on Primary Sequence and Glycosylation

Pharmaceuticals, 2019
The demand for reliable comparability studies of biosimilars grows with their increased market share. These studies focus on physicochemical, structural, functional and clinical properties to ensure that a biosimilar has no significant differences to the
R. Fazel, Yudong Guan, B. Vaziri, C. Krisp, Laura Heikaus, Amirhossein Saadati, Siti Nurul Hidayah, M. Gaikwad, H. Schlüter   +8 more
semanticscholar   +1 more source

Outcomes of adalimumab biosimilar nonmedical switches in children and young adults with inflammatory bowel disease

JPGN Reports, EarlyView.
Abstract Objectives Adalimumab biosimilars are as safe and effective compared to the originator. Adult patients with inflammatory bowel disease (IBD) who switched to a biosimilar have comparable outcomes, but pediatric data are limited. This study evaluates clinical outcomes of children and young adults with IBD following a nonmedical, insurance‐driven
Daniel Himelstein, Megan McNicol, Mahmoud Abdel‐Rasoul, Brendan M. Boyle, Hilary K. Michel, Ross Maltz   +5 more
wiley   +1 more source

Statistical assessment of biosimilar products

, 2010
[[abstract]]Biological products or medicines are therapeutic agents that are produced using a living system or organism. Access to these life-saving biological products is limited because of their expensive costs. Patents on the early biological products
Chow, SC;Liu, JP
core   +1 more source

A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 to week 48)

Arthritis Research & Therapy
Background Equivalent efficacy and comparable pharmacokinetic, immunogenicity, and safety profiles of the biosimilar BAT1806/BIIB800 and reference tocilizumab (TCZ) in participants with moderate-to-severe rheumatoid arthritis (RA) have been reported up ...
Xiaomei Leng, Piotr Leszczyński, Slawomir Jeka, Shengyun Liu, Huaxiang Liu, Malgorzata Miakisz, Jieruo Gu, Lali Kilasonia, Mykola Stanislavchuk, Xiaolei Yang, Yinbo Zhou, Qingfeng Dong, Marian Mitroiu, Janet Addison, Mourad F. Rezk, Xiaofeng Zeng   +15 more
doaj   +1 more source

Real Life Clinical Effectiveness of Razumab® (World’s First Biosimilar Ranibizumab) in Wet Age-Related Macular Degeneration: A Subgroup Analysis of Pooled Retrospective RE-ENACT Study

, 2018
Wet age-related macular degeneration (wet AMD), a leading cause of vision loss globally, is a late-onset, multifactorial retinal degenerative disease.
S. Sharma, K. Ma, Intas Pharmaceuticals Ltd. Ahmedabad Gujarat India Medical Services   +2 more
semanticscholar   +1 more source