Results 51 to 60 of about 22,015 (248)

Emergence of the Biosimilar Sector and Opportunities of Developing Country Suppliers [PDF]

, 2011
As biologic products begin to come off-patent, a market is emerging for biosimilars (also known as biogenerics or follow-on biologics). Firms from emerging countries such as India and China have dominated the production of active ingredients in ...
Huzair, Farah, Kale, Dinar
core  

Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. [PDF]

, 2016
Biosimilars present a necessary and timely opportunity for physicians, patients and healthcare systems. If suitably developed clinically, manufactured to the correct standards and used appropriately, they can positively impact on the financial ...
Arnold, Dirk, Cardoso, Fatima, Casali, Paolo G., Cervantes, Andrés, Ciardiello, Fortunato, Douillard, Jean-Yves, Eggermont, Alexander M. M., Eniu, Alexandru, Giuliani, Rosa, Jassem, Jacek, McGregor, Keith, Pentheroudakis, George, Peters, Solange, Rauh, Stefan, Stahel, Rolf A., Tabernero, Josep, Universitat Autònoma de Barcelona, Voest, Emile, Vyas, Malvika, Zielinski, Christoph C.   +19 more
core   +5 more sources

Early‐stage health technology assessment of a curative gene therapy for multiple sclerosis

British Journal of Clinical Pharmacology, EarlyView.
Aims Multiple sclerosis (MS) is associated with significant early morbidity, reduced life expectancy and substantial healthcare and societal costs. The primary objective of this study is to assess the early cost‐effectiveness potential of a novel gene therapy, IMMUTOL, for MS compared with current high‐efficacy treatment sequences.
Attila Imre, Balázs Nagy, Rok Hren
wiley   +1 more source

Biosimilars

TURKDERM, 2022
For a drug to be defined as a biosimilar, it should be fairly similar to the previously approved original or reference product. The minor variances in its inactive ingredients should not pose clinically significant differences from the reference product in terms of safety and efficacy potency.
openaire   +4 more sources

Native mass spectrometry combined with enzymatic dissection unravels glycoform heterogeneity of biopharmaceuticals

Nature Communications, 2018
The specific glycosylation patterns of biological drugs often impact the efficacy and safety of the therapeutic product. Here the authors describe a native mass spectrometry approach that allows the resolution of highly complex glycosylation patterns on ...
Therese Wohlschlager, Kai Scheffler, Ines C. Forstenlehner, Wolfgang Skala, Stefan Senn, Eugen Damoc, Johann Holzmann, Christian G. Huber   +7 more
doaj   +1 more source

Fostering medication review competence of pharmacy students: An assessment by students and their preceptors after advanced‐level practical internship

British Journal of Clinical Pharmacology, EarlyView.
Aims The aim of this study was to introduce a new assessment method for pharmacy students' real‐life competence in reviewing medications after obligatory advanced‐level practical internship in Finland. Methods The new medication review (MR) competence assessment method consisted of (1) a self‐assessment by pharmacy students and (2) a performance ...
Katja Leiman, Aleksi Westerholm, Tero Vahlberg, Noora Lias, Tanja Lindholm, Marja Airaksinen   +5 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

Will There Be a Role for a Short-Acting Biosimilar Erythropoiesis-Stimulating Agent in US Nephrology Practice? [PDF]

, 2019
Patent protection for pharmaceuticals in the United States is very robust and perhaps there is no greater example than epoetin alfa. Since the approval of epoetin alfa by the Food and Drug Administration (FDA) in 1989, the developer, Amgen (Thousand Oaks,
Wish, Jay B.
core   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results [PDF]

, 2017
Background: Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy,
Argüelles Arias, Federico, Castro Laria, Luisa, Guerra Veloz, María Fernanda, Maldonado Pérez, Belén, Merino Bohórquez, Vicente, Perea Amarillo, Raúl, Romero Gómez, Manuel, Vilches Arenas, Ángel   +7 more
core