Results 51 to 60 of about 21,799 (237)

Manufacturing Barriers to Biologics Competition and Innovation [PDF]

open access: yes, 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

Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: A survey of physicians and pharmacists in Ireland [PDF]

open access: yes, 2017
Increasing numbers of biosimilar medicines are becoming available. The objective of this survey was to assess awareness of and attitudes to biosimilars amongst physicians (medical specialists and General Practitioners (GPs)) and community pharmacists in ...
Bermingham, Margaret   +6 more
core   +1 more source

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer   +4 more
wiley   +1 more source

PGI12 Mean Annual Cost Of Patients Hospitalized For Chronic Hepatitis C In France: The Hepc-Lone Study [PDF]

open access: yes, 2014
Las relaciones laborales marítimas se singularizan por caracteres que han propiciado la necesidad de formular instrumentos que tutelen los derechos de la gente de mar. Entre las singularidades más destacadas está el centro de trabajo: el buque.
Abergel, A.   +6 more
core   +3 more sources

Multimodal Chromatography in the Downstream Processing of mAb‐Based Products: Mechanisms, Strategies, and Applications

open access: yesBiotechnology and Bioengineering, EarlyView.
ABSTRACT Multimodal chromatography has emerged as a powerful tool for the purification of monoclonal antibodies (mAbs) and their derivatives—including antibody fragments (Fabs), Fc‐fusions, bispecific (BsAb), and antibody–drug conjugates (ADCs)—offering enhanced selectivity through the integration of ionic, hydrophobic, hydrogen‐bonding, and π–π ...
Amin Javidanbardan   +4 more
wiley   +1 more source

Authorisation of Non-Innovator Biotherapeutic (Biosimilar) Products in the USA

open access: yesБиопрепараты: Профилактика, диагностика, лечение, 2019
European competent authorities began to elaborate scientific principles of development of non-innovator biotherapeutic (biosimilar) products in the early noughties, and in 2009 these principles were approved at the WHO International Conference in Seoul ...
A. A. Soldatov   +3 more
doaj   +1 more source

Uptake of Biosimilar Infliximab in the UK, France, Japan, and Korea: Budget Savings or Market Expansion Across Countries?

open access: yesFrontiers in Pharmacology, 2020
ObjectiveTo compare the market dynamics of biosimilar infliximab among four Organization for Economic Cooperation and Development (OECD) countries (UK, France, Japan, and Korea) where supply-side and demand-side policies varied greatly, given high and ...
Yujeong Kim   +8 more
doaj   +1 more source

Efficacy and safety of the biosimilar infliximab CT-P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort [PDF]

open access: yes, 2016
Background and Aims: Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking.
Balázs Szalay   +24 more
core   +3 more sources

Artificial intelligence and machine learning‐assisted digital applications for biopharmaceutical manufacturing

open access: yesBiotechnology Progress, EarlyView.
Abstract Artificial intelligence and automation are no longer just buzzwords in the biopharmaceutical industry. The manufacturing of a class of biologics, comprising monoclonal antibodies, cell therapies, and gene therapies, is far more complex than that of traditional small molecule drugs.
Shyam Panjwani, Hao Wei, John Mason
wiley   +1 more source

Efficacy and Safety of Bevacizumab Biosimilar (Encoda) Compared With Reference Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer: A Multicenter, Real-World Study

open access: yesClinical Medicine Insights: Oncology
Background: The bevacizumab biosimilar (Encoda), which was approved by the National Medical Products Administration (NMPA) in China in 2019, is a biosimilar of bevacizumab.
Han Shan   +5 more
doaj   +1 more source

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