Results 51 to 60 of about 790,096 (261)

Characterization of Full‐Length Antibody Complexes Through HDX‐Mass Spectrometry Coupled With NMR Spectroscopy: New Insight Into Avelumab/PD‐L1 Interaction

Angewandte Chemie International Edition, EarlyView.
Combining HDX‐MS and NMR enables the mapping of epitopes and paratopes in full‐length antibody complexes, revealing transient interactions and potential artifacts. ABSTRACT Recombinant biomacromolecules have significantly transformed pharmaceuticals, in particular monoclonal antibodies (mAbs) that target key areas in oncology, immunology, inflammation,
Francesca Sacco, Fabio Baroni, Angela Capolupo, Sofia Petrocchi, Jonathan Zöller, Linda Cerofolini, Pasquale Russomanno, Rebecca Calamandrei, Bianca Susini, Siyu Lin, Fabio D'Amici, Enrico Ravera, Julian Langer, Marco Fragai   +13 more
wiley   +1 more source

Biosimilars; a unique opportunity for Iran national health sector and national pharmaceutical industry [PDF]

DARU Journal of Pharmaceutical Sciences, 2012
In 1980s, medicines produced through recombinant DNA technology created a novel opportunity for management of several debilitating and life threatening diseases. However, these medicines are very expensive and therefore not affordable for many patients especially those living in low resourced countries.
openaire   +2 more sources

Development and validation of a method for the determination of the specific activity of recombinant monoclonal antibody eculizumab

Тонкие химические технологии, 2020
Objectives. Developing reliable and accurate analytical methods is necessary for comparative pharmaceutical analysis using physicochemical, biological (in vitro), preclinical, and clinical trials.
D. I. Zybin, A. S. Seregin, A. D. Askretkov, N. V. Orlova, Yu. A. Seregin, A. I. Prostyakova, D. V. Kapustin   +6 more
doaj   +1 more source

Cost effectiveness of using trastuzumab biosimilars compared to trastuzumab original drugs to treat breast cancer in a hospital setting

Breast, 2023
Introduction: Subcutaneous (SC) drug administration, such as the Herceptin® in an oncology day hospital reduces the administration time of trastuzumab.
Eric C. Barat, Marianne L.E. Arrii, Annaelle Soubieux-Bourbon, Mikaël Daouphars, Rémi Varin, Patrick R. Tilleul   +5 more
doaj   +1 more source

DISCONTINUATION RATES FOLLOWING A SWITCH FROM A REFERENCE TO A BIOSIMILAR BIOLOGIC IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS [PDF]

Arquivos de Gastroenterologia, 2020
BACKGROUND: Biologics have revolutionized the treatment of inflammatory bowel disease (IBD). However, these drugs had a significant influence on treatment-related costs, which resulted in the development of biosimilars.
Natália Sousa Freitas QUEIROZ, Rogerio SAAD-HOSSNE, Renata de Sá Brito FRÓES, Francisco Guilherme Cancela e PENNA, Stefania Burjack GABRIEL, Adalberta Lima MARTINS, Fabio Vieira TEIXEIRA   +6 more
doaj   +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

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

EFFICACY AND SAFETY OF THE PROPOSED BIOSIMILAR AFLIBERCEPT, SDZ-AFL, IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

Retina
Supplemental Digital Content is Available in the Text. The Phase 3 Mylight study confirmed that proposed biosimilar aflibercept (SOK583A1; Sandoz) is clinically equivalent to its reference biologic in treatment outcomes for neovascular age-related ...
A. Bordon, Peter K. Kaiser, Armin Wolf, L. Cen, Jens Heyn, Dragan Urosevic, Francis Dodeller, Lisa Allmannsberger, Rufino Silva   +8 more
semanticscholar   +1 more source

4CPS-008 Impact of pharmaceutical interview in patient acceptance of insulin glargine’s biosimilar 100UI/ml [PDF]

Section 4: Clinical Pharmacy Services, 2019
Background The insulin glargine’s biosimilar (IB) has been marketed since 2016, and is far less costly for the healthcare system, but their prescription is not yet predominant. To prescribe a biosimilar, the patient must be informed on what constitutes a biosimilar and must provide his agreement.
M Malassigné, M Megne-Wabo, V Rigalleau, K Mohammedi, F Xuereb, D Breilh   +5 more
openaire   +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