Results 181 to 190 of about 681,456 (227)

Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions

The Lancet Oncology, 2020
The EU, the USA, and Japan account for the majority of biological pharmacotherapy use worldwide. Biosimilar regulatory approval pathways were authorised in the EU (2006), in Japan (2009), and in the USA (2015), to facilitate approval of biological drugs ...
Charles L. Bennett, Charles L. Bennett, M. Schoen, S. Hoque, B. Witherspoon, D. Aboulafia, Catherine S. Hwang, Paul Ray, P. Yarnold, Brian K Chen, Benjamin L. Schooley, Matthew A. Taylor, M. D. Wyatt, W. Hrushesky, Y. T. Yang   +14 more
semanticscholar   +1 more source

Development of Biosimilar Aflibercept SDZ-AFL

Current Therapeutic Research
Purpose Aflibercept is a recombinant fusion protein that binds with high affinity to vascular endothelial growth factor A (VEGF-A), and other growth factors, reducing pathological neovascularization and abnormal vascular permeability.
Francis Dodeller, P. Alliger, Jens Heyn, Dragan Urosevic, Lisa Allmannsberger, C. Wersig, Rufino Silva   +6 more
semanticscholar   +1 more source

Pharmaceutical advice by phone enhances use of infliximab biosimilars

2018
25.
van Eijk, SC, Arndt, LK, Neitemeier, S
openaire   +2 more sources

Biological and Biosimilar Medicines in Contemporary Pharmacotherapy for Metabolic Syndrome

Pharmaceutics
The discovery of new drugs offers valuable alternatives, particularly for treating diseases that are resistant to existing therapies or involving complex, multi-organ conditions such as metabolic syndrome. Although treatment algorithms are generally well
Wiktoria Górecka, Daria Berezovska, Monika Mrozińska, Grażyna Nowicka, M. Czerwińska   +4 more
semanticscholar   +1 more source

Ranibizumab biosimilar (Oceva) – real-world experience from India (RORE study)

Expert Opinion on Biological Therapy
Background To evaluate early real-world clinical outcomes on the safety and efficacy of the ranibizumab biosimilar (Oceva, Sun Pharmaceuticals, India). Research design and methods A multicenter, retrospective, uncontrolled observational study evaluating ...
Ashish Sharma, Jay Sheth, Chitaranjan Mishra, Debdulal Chakraborty, Bhagyashree Meshram, Somy Purohit   +5 more
semanticscholar   +1 more source

Regulatory Challenges and Clinical Implications of Biosimilar Drugs

Journal of Advances and Scholarly Researches in Allied Education
Medications that are biosimilar are very similar to biologics that have been authorised by the FDA. When it comes to speciality treatment areas like immunology, endocrinology, and cancer, biosimilar medications might be helpful since the sponsors of ...
Y. Alanazi, Basil Naser Mubarak Alamri
semanticscholar   +1 more source

Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a case analysis in Ecuador

Generics and Biosimilars Initiative Journal, 2021
At the beginning of the COVID-19 pandemic, Ecuador was unprepared for the overwhelming number of COVID-19 cases. As the general population started to see the eff ects of the pandemic, unproven treatments and medications were sought by the population to try to ameliorate the impact of the pandemic.
Esteban Ortiz-Prado, Enrique Teran, Raul Patricio Fernandez Naranjo, Doménica Cevallos-Robalino, Eduardo Vasconez, Alex Lister   +5 more
openaire   +1 more source

Evaluation of adverse events associated with filgrastim originator and biosimilar using a spontaneous reporting system database.

Pharmazie, 2020
Biosimilar products of filgrastim have become available for improved sustainability of cancer care; however, the real-world safety profile remains unknown.
Iku Niinomi, Keiko Hosohata, Saki Oyama, Ayaka Inada, Tomohito Wakabayashi, K. Iwanaga   +5 more
semanticscholar   +1 more source

Biosimilars and Information Exchange in Australian Pharmaceutical Patent, Trade Secret and Data Exclusivity Arrangements

2022
More specifically, this thesis examines the information exchange between originator manufacturers and biosimilar manufacturers related to patents and data exclusivity, and how the information exchange affects biosimilars and biosimilar development.
openaire   +1 more source

Rapid characterization of structural and functional similarity for a candidate bevacizumab (Avastin) biosimilar using a multipronged mass-spectrometry-based approach.

Drug Testing and Analysis, 2019
The ongoing shift from small molecule drugs to protein therapeutics in the pharmaceuticals industry presents a considerable challenge to generic drug developers who are increasingly required to demonstrate biosimilarity for biological macromolecules, a ...
Kerene A Brown, S. Rajendran, Jason Dowd, Derek J. Wilson   +3 more
semanticscholar   +1 more source