Results 61 to 70 of about 30,003 (287)

Clinical considerations for biosimilar antibodies [PDF]

, 2013
Biosimilar agents are approximate copies of branded biologic therapies. Since the first biosimilar was authorized in the European Union in 2006, fifteen additional agents have been approved by the European Medicines Agency, including two biosimilar ...
Mellstedt, Håkan
core   +1 more source

The challenge of biosimilars

Annals of Oncology, 2008
The purpose of this report was to review issues associated with the introduction of alternative versions of biosimilars used in the oncology setting.Data were obtained by searches of MEDLINE, PubMed, references from relevant English-language articles, and guidelines from the European Medicines Agency.When biosimilars are approved in EU, they will be ...
Håkan Mellstedt, Dietger Niederwieser, H. Ludwig   +2 more
openaire   +3 more sources

Sentinel dosing: A proposed algorithm to guide decision making on which cohorts in early phase clinical pharmacology trials should use this approach

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this paper is to describe a proposal for an algorithm to guide decision making on which cohorts in early phase pharmacology trials should employ a sentinel approach, thereby standardising and harmonising practices, and improving decision making around sentinel dosing.
Jules A. A. C. Heuberger, Perry de Jongh, Ewoud‐Jan van Hoogdalem, Wim Tamminga, Pieter de Graeff, Geert Jan Groeneveld   +5 more
wiley   +1 more source

Manufacturing Barriers to Biologics Competition and Innovation [PDF]

, 2016
As finding breakthrough small-molecule drugs gets harder, drug companies are increasingly turning to “large molecule” biologics. Although biologics represent many of the most promising new therapies for previously intractable diseases, they are extremely
Price, W. Nicholson, II, Rai, Arti K.
core   +2 more sources

The Daring of Biosimilars

Archives of Biotechnology and Biomedicine, 2017
The so-called “biotechnological revolution” is changing the structure of the Pharmacopoeia [1]. The space of biological products, previously limited to blood products and vaccines, grew from the introduction of first recombinant therapeutics in the 1980s until attaining a 25% by value of the pharmaceutical market. This share is expected to reach 50% in
Nuris Ledón, Agustin Lage
openaire   +2 more sources

Techno‐Economic Analysis of Membrane‐Based Purification Platforms for AAV Vector Production

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Technologies for large‐scale manufacturing of viral vectors for gene therapies, such as tangential flow filtration and membrane chromatography, are under development. In these early stages of process development, techno‐economic analyses are useful for identifying membrane properties yielding the greatest impact on process performance. In this
Juan J. Romero, Eleanor W. Jenkins, Jacob I. Monroe, S. Ranil Wickramasinghe, Xianghong Qian, Dibakar Bhattacharyya, Scott M. Husson   +6 more
wiley   +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

A Surface Plasmon Resonance‐Based Integrated Assay for Quantification and Glycosylation Characterization of Monoclonal Antibodies in Crude Heterogeneous Samples

Biotechnology and Bioengineering, EarlyView.
ABSTRACT The rise in cancer, autoimmune, inflammatory, and infectious diseases in recent decades has led to a surge in the development of monoclonal antibodies (mAbs) therapies, now the most widely used family of biologics. To meet the growing global demand, biopharmaceutical industries are intensifying their production processes.
Ilona Metayer, Catherine Forest‐Nault, Julie Guimond, Simon Joubert, Olivier Henry, Yves Durocher, Gregory De Crescenzo, Jimmy Gaudreault   +7 more
wiley   +1 more source

Charge Variants of an Avastin Biosimilar Isolation, Characterization, In Vitro Properties and Pharmacokinetics in Rat. [PDF]

PLoS ONE, 2016
The similarity between a proposed biosimilar product and the reference product can be affected by many factors. This study is designed to examine whether any subtle difference in the distribution of the charge variants of an Avastin biosimilar can affect
Yan-Yan Zhao, Ning Wang, Wan-Hui Liu, Wen-Jie Tao, Li-Li Liu, Zhen-Duo Shen   +5 more
doaj   +1 more source

Long term efficacy, safety and immunogenicity of biosimilar infliximab after one year in a prospective nationwide cohort [PDF]

, 2018
K
Banai, János, Bene, László, Farkas, Klaudia, Gasztonyi, Beáta, Gecse, Krisztina B., Golovics, Petra Anna, Gönczi, Lóránt, Kristóf, Tünde, Kürti, Zsuzsanna, Lakatos, László, Lakatos, Péter László, Lovász, Barbara Dorottya, Miheller, Pál, Molnár, Tamás, Nagy, Ferenc, Palatka, Károly, Papp, Mária, Patai, Árpád, Rutka, Mariann, Salamon, Ágnes, Szalay, Balázs, Szamosi, Tamás, Szepes, Zoltán, Tóth, Gábor Tamás, Vincze, Áron, Végh, Zsuzsanna   +25 more
core   +1 more source