Results 1 to 10 of about 5,542 (243)

Portuguese Position Paper on the Use of Biosimilars in Psoriasis [PDF]

Acta Médica Portuguesa, 2016
Keywords: Biological Agents; Biosimilar Pharmaceuticals; Portugal; Psoriasis/drug therapy.
Tiago Torres, Ana Ferreira, Paulo Ferreira, Martinha Henriques, Luiz Leite, Sofia Magina, Gabriela Marques Pinto, Hugo Oliveira, Artur Sousa Basto, Rui Tavares Bello, Paulo Varela, Antonio Massa, Manuela Selores, Paulo Filipe, On behalf of The Portuguese College of Dermatology, On behalf of The Portuguese Society of Dermatology and Venereology   +15 more
doaj   +4 more sources

Exploring Stakeholder Perceptions and Experience of Biosimilar Insulin Switching: A Scoping Review [PDF]

Endocrinology, Diabetes & Metabolism
Background The option to switch patients to more cost‐effective biosimilar insulins has been available since 2014, and the market share for these medicines has been slowly increasing since then. This scoping review aimed to identify the current knowledge
Ben Hindley, Sally Wright, Cheong Ooi, Ricardo Da Costa, Louise Cope   +4 more
doaj   +2 more sources

Population Pharmacodynamic Modelling of the CD19+ Suppression Effects of Rituximab in Paediatric Patients with Neurological and Autoimmune Diseases

Pharmaceutics, 2023
Background: Limited pharmacotherapy and the failure of conventional treatments in complex pathologies in children lead to increased off-label use of rituximab.
Natalia Riva, Lucas Brstilo, Aymara Sancho-Araiz, Manuel Molina, Andrea Savransky, Georgina Roffé, Marianela Sanz, Silvia Tenembaum, Maria M. Katsicas, Iñaki F. Trocóniz, Paula Schaiquevich   +10 more
doaj   +1 more source

Comparative safety assessments of the biosimilar APZ001 and Erbitux in pre-clinical animal models [PDF]

Acta Cirúrgica Brasileira, 2018
Purpose: To evaluate the toxicity of Erbitux as well as its biosimilar APZ001 antibody (APZ001) in pre-clinical animal models including mice, rabbits and cynomolgus monkeys.
Xiaofei Wang, Jianmin Guo, Xinyu Deng, Yuankeng Huang, Caiguo Ye, Huiqing Liang, Junhua Rao, Wei Yang   +7 more
doaj   +2 more sources

Learnings from Regional Market Dynamics of Originator and Biosimilar Infliximab and Etanercept in Germany

Pharmaceuticals, 2020
Drug budget and prescription control measures are implemented regionally in Germany, meaning that the uptake of pharmaceuticals, including biosimilars, can vary by region.
Evelien Moorkens, Teresa Barcina Lacosta, Arnold G. Vulto, Martin Schulz, Gabriele Gradl, Salka Enners, Gisbert Selke, Isabelle Huys, Steven Simoens   +8 more
doaj   +1 more source

Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines [PDF]

, 2018
Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations to identify challenges ...
Anvisa, Castaneda-Hernandez, CBER, CBER, CBER, CBER, CBER, CBER, CBER, CDSCO, CFDA, Christl, Cofepris, Gautam, Lozda, MCC, Minghetti, Olech, Priori, Rushvi, Schiestl   +20 more
core   +5 more sources

Knowledge and Viewpoints on Biosimilar Monoclonal Antibodies among Asian Physicians: Comparison with European Physicians

The Korean Journal of Gastroenterology, 2019
Background/Aims: Current knowledge and viewpoints regarding biosimilars among physicians in Asia are unknown, even though these were investigated by European Crohn’s and Colitis Organization (ECCO) members in 2013 and 2015.
Soo-Kyung Park, Won Moon, Eun Soo Kim, Sang Hyun Park, Dong Il Park   +4 more
doaj   +1 more source

Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for a systematic review and meta-analysis

Systematic Reviews, 2021
Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide.
Bruna O. Ascef, Matheus O. Almeida, Ana Cristina de Medeiros Ribeiro, Danieli C. O. Andrade, Haliton A. de Oliveira Júnior, Tiago V. Pereira, Patrícia C. de Soárez   +6 more
doaj   +1 more source

Forced Degradation Testing as Complementary Tool for Biosimilarity Assessment [PDF]

, 2019
Oxidation of monoclonal antibodies (mAbs) can impact their efficacy and may therefore represent critical quality attributes (CQA) that require evaluation.
Dyck, Yan Felix Karl, Jabs, Wolfgang, Joseph, Jan Felix, Parr, Maria Kristina, Rehm, Daniel, Sandig, Volker, Winkler, Karsten   +6 more
core   +1 more source

Evaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system database

Journal of Pharmaceutical Health Care and Sciences, 2019
Background Infliximab (IFX) has changed the management of many life-threatening immune-mediated diseases. The high cost of IFX and its patent expiry have led to pharmaceutical companies developing a biosimilar; however, its safety profile remains unknown
Iku Niinomi, Keiko Hosohata, Yasuhiro Mori, Yuki Yamaguchi, Tomohito Wakabayashi, Mayako Uchida, Kazunori Iwanaga   +6 more
doaj   +1 more source