Results 61 to 70 of about 22,015 (248)

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

British 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, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

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

Biotechnology 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, Marco P․ C․ Marques, Ana M. Azevedo, Daniel G. Bracewell, Stephen Goldrick   +4 more
wiley   +1 more source

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

Биопрепараты: 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, Zh. I. Avdeeva, V. P. Bondarev, V. D. Mosyagin   +3 more
doaj   +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

Design of experiments‐guided membrane capture facilitates integration of continuous virus inactivation using Phi6 as a surrogate virus in an intensified downstream process

Biotechnology Progress, EarlyView.
Abstract The growing demand for cost‐efficient and flexible biomanufacturing has increased interest in process‐intensified downstream platforms. This study evaluates an intensified monoclonal antibody (mAb) purification sequence, where two unit operations traditionally performed in batch mode—Protein A capture and low pH virus inactivation (VI)—are ...
Mario Grünberg, Lisa Lipski, Gabriel Fisicaro, Thomas Duvignau, Karolina Meyer‐Heinrichs, Diana Carmen Mocsy, Thomas‐Josef Filz, Bastian Quaas, Alexandra Stützer   +8 more
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

Clinical 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, Mengmeng Wang, Shuohan Huang, Hongyue Liu, Jiyong Liu, Qiong Du   +5 more
doaj   +1 more source

Sintilimab Plus Bevacizumab Biosimilar Versus Sorafenib as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Cost-Effectiveness Analysis

Frontiers in Pharmacology, 2022
Objective: The ORIENT-32 clinical trial revealed that sintilimab plus bevacizumab biosimilar significantly improved the median progression-free survival and median overall survival (OS) compared with sorafenib.
Ye Peng, Xiaohui Zeng, Liubao Peng, Qiao Liu, Lidan Yi, Xia Luo, Sini Li, Liting Wang, Shuxia Qin, Xiaomin Wan, Chongqing Tan   +10 more
doaj   +1 more source

Measuring the Impact of the Substitution of Innovator Biologics With Biosimilars on Uptake and Costs Among Ontario Public Drug Benefit Recipients

Clinical Pharmacology &Therapeutics, EarlyView.
In Ontario, biologics have historically represented a small proportion of public drug claims but a large proportion of spending. Biosimilars, lower cost alternatives to biologics, offer a potential solution to the rising spending on biologics. From March 2023 to January 2024, the Ontario Ministry of Health required public drug program beneficiaries on ...
Anita Iacono, Martin K. H. Ho, Joanna Yang, Tonya Campbell, William Wynne, Dana Shearer, Lene Andersen, Eric Majer, Shaleesa Ledlie, Mina Tadrous, Tara Gomes   +10 more
wiley   +1 more source

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

Frontiers 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, Hye-Young Kwon, Hye-Young Kwon, Brian Godman, Brian Godman, Brian Godman, Evelien Moorkens, Steven Simoens, SeungJin Bae   +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]

, 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, Barbara D. Lovász, Best, Beáta Gasztonyi, Ferenc Nagy, Gábor T. Tóth, János Banai, Klaudia Farkas, Krisztina B. Gecse, Károly Palatka, Lilla Lakner, László Bene, László Lakatos, Mária Papp, Márk Juhász, Petra Anna Golovics, Péter L. Lakatos, Tamás Molnár, Tamás Szamosi, Tünde Kristóf, Zoltán Szepes, Ágnes Anna Csontos, Ágnes Salamon, Áron Vincze, Árpád Patai   +24 more
core   +3 more sources