Results 61 to 70 of about 166 (149)

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

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

Biosimilar filgrastim treatment patterns and prevention of febrile neutropenia: a prospective multicentre study in France in patients with solid tumours (the ZOHé study)

BMC Cancer, 2018
Background The ZOHé study was a prospective, non-interventional, multicentre study in France to assess the use of biosimilar filgrastim Zarzio® (Sandoz filgrastim) in routine clinical practice in patients at risk of neutropenia-inducing chemotherapy (CT).
Henri Roché, Jean-Christophe Eymard, Abderraouf Radji, Alain Prevost, Rafik Diab, Michele Lamuraglia, Ravaka-Fatoma Soumoudronga, Isabelle Gasnereau, Alain Toledano   +8 more
doaj   +1 more source

Recent Advances (2023–2025) of Capillary Electrophoresis‐Mass Spectrometry (CE‐MS) for Top‐Down Proteomics

Mass Spectrometry Reviews, EarlyView.
ABSTRACT Top‐down proteomics (TDP) characterizes proteoforms in cells, tissues, and biofluids, in discovery mode and on a global scale, requiring analytical tools with high peak capacity for proteoform separation and high sensitivity for proteoform detection, given the extremely high proteoform complexity and wide proteoform concentration dynamic range.
Guijie Zhu, David A. Alvarez Rodriguez, Noah Gould, Alexander R. Ivanov, Kevin Jooß, Liangliang Sun   +5 more
wiley   +1 more source

Efficacy, safety, and immunogenicity of biosimilars compared with the biologic etanercept in patients with rheumatoid arthritis: a systematic review and meta-analysis

Systematic Reviews
Background Biosimilar etanercept presents itself as an innovative therapeutic opportunity for inflammatory and autoimmune diseases, however, its efficacy, safety, and immunogenicity in relation to the reference biological agent for the treatment of ...
Aurélio Matos Andrade, Juliana da Motta Girardi, Erica Tatiane da Silva, Jakeline Ribeiro Barbosa, Daniella Cristina Rodrigues Pereira   +4 more
doaj   +1 more source

Advancing pharmacometrics in Africa—Transition from capacity development toward job creation

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 407-419, March 2025.
Abstract Trained pharmacometricians remain scarce in Africa due to limited training opportunities, lack of a pharmaceutical product development ecosystem, and emigration to high‐income countries. The Applied Pharmacometrics Training (APT) fellowship program was established to address these gaps and specifically foster job creation for talent retention.
Goonaseelan (Colin) Pillai, Samer Mouksassi, Innocent G. Asiimwe, Craig R. Rayner, Steven Kern, Phumla Sinxadi, Paolo Denti, Eric Decloedt, Catriona Waitt, Bernhards R. Ogutu, Rik de Greef   +10 more
wiley   +1 more source

Disease remission and sustained remission after etanercept biosimilar or originator initiation in rheumatoid arthritis: an interim real-world analysis

Arthritis Research & Therapy
Background We compared time to first remission and prevalence of sustained remission in participants with rheumatoid arthritis (RA) initiating etanercept biosimilar (ETA-B) or originator (ETA-O).
Marina G. Birck, Jessica Boivin, Laura Yan, Nathalie Carrier, Cristiano S. Moura, Walter P. Maksymowych, Gilles Boire, Denis Choquette, Luck Lukusa, Michael Mallinson, Linda Wilhelm, Autumn Neville, Sasha Bernatsky   +12 more
doaj   +1 more source

Update on Non‐Biological and RNA‐Based Therapeutics in Chronic Inflammatory Diseases: Precision Medicine Through Small Molecules: An EAACI Position Paper

Allergy, EarlyView.
ABSTRACT In the last decades, critical advancements in research technology and knowledge on disease mechanisms steered therapeutic approaches for chronic inflammatory diseases towards unprecedented target specificity. For allergic and chronic lung diseases, biologic drugs pioneered this goal, acquiring on the way—through the clinical use of monoclonal ...
F. Roth‐Walter, I. M. Adcock, C. Benito‐Villalvilla, R. Bianchini, L. Bjermer, G. Caramori, L. Cari, K. F. Chung, Z. Diamant, I. Eguiluz‐Gracia, E. F. Knol, M. Jesenak, F. Levi‐Schaffer, G. Nocentini, L. O'Mahony, O. Palomares, F. Redegeld, M. Sokolowska, B. Van Esch, M. Zurlo, C. Stellato   +20 more
wiley   +1 more source

Exploring market dynamics of biological including biosimilar treatments for retinal diseases in Europe: An interrupted time‐series analysis

Acta Ophthalmologica, EarlyView.
Abstract Purpose To assess the impact of biosimilar ranibizumab and on‐patent faricimab market entry on pricing and utilization trends and describe national variation in off‐label bevacizumab use in Europe. Methods Interrupted time series analysis of quarterly sales data (Q1 2018–Q2 2024) in 11 European countries evaluated ranibizumab utilization and ...
Elif Car, Isabelle Huys, Steven Simoens, Arnold G. Vulto   +3 more
wiley   +1 more source

Novel approaches for drug development against chronic primary pain: A systematic review

British Journal of Pharmacology, EarlyView.
Abstract Chronic primary pain (CPP) persisting for more than 3 months, associated with significant emotional distress without any known underlying cause, is an unmet medical need. Traditional or adjuvant analgesics do not provide satisfactory pain relief for a great proportion of these patients.
Valéria Tékus, Éva Borbély, Andreas Goebel, Ralf Baron, Zsófia Hajna, Zsuzsanna Helyes   +5 more
wiley   +1 more source