Results 61 to 70 of about 790,096 (261)

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

Treatment Patterns, Effectiveness, and Safety of Originator Insulin Glargine versus Insulin Glargine-yfgn within the Veterans Health Administration

Pharmacoepidemiology
We described insulin glargine (originator) and insulin glargine-yfgn (biosimilar) treatment patterns, assessed effectiveness and safety outcomes, and identified reasons for switching back to the originator product from the biosimilar.
Samantha Walczuk, Francesca E. Cunningham, Xinhua Zhao, Diane Dong, Peter A. Glassman, Donald R. Miller, Deborah Khachikian, Anthony Au, Cedric Salone, Kelly Bryan, Qoua Her, Sherrie L. Aspinall   +11 more
doaj   +1 more source

Pooled Multicenter Safety Analysis of Lupin’s Intravitreal Biosimilar Ranibizumab (Ranieyes) in Chorioretinal Vascular Diseases

Ophthalmology and Therapy
This study aims to evaluate the ocular and systemic safety profiles of intravitreal biosimilar ranibizumab Ranieyes (Lupin Pharmaceuticals, Mumbai, India) in real-world clinical settings across multiple chorioretinal vascular diseases, including ...
Debdulal Chakraborty, T. Sinha, Sourav Sinha, Aniruddha Maiti, Angshuman Mukherjee, K. Nandi, Sudipta Das, S. Majumdar, Dinesh Rungta, Ranabir Bhattacharya   +9 more
semanticscholar   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

A Comparison of the Immunogenicity of Intravenous BAT1806, a Tocilizumab Biosimilar, and Its Reference Product

Rheumatology and Therapy
Introduction Biosimilars need to demonstrate similarity in terms of quality, pharmacokinetics (PK), efficacy, safety, and immunogenicity. Here, we report the outcome of a comprehensive evaluation of the immunogenicity of the biosimilar BAT1806 compared ...
Hans C. Ebbers, Peter C. Taylor, Xiaomei Leng, Wei Wei, Niamh M. Kinsella, Yinbo Zhou, Xiaolei Yang, Paul Chamberlain   +7 more
doaj   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Launching biosimilar rituximab: an industry opinion on biosimilar uptake in Europe

, 2017
Richard Trollope and Sue Johnson talk with Henry Ireland, Senior Editor about the recent approval of biosimilar rituximab (Truxima®) & the current state of biosimilar uptake across Europe Richard Trollope, Head of Biosimilars, Mundipharma ...
Henry Ireland, Richard Trollope, Sue Johnson   +2 more
core   +1 more source

A bibliometric analysis of the global research on biosimilars

Journal of Pharmaceutical Policy and Practice, 2018
Background Biosimilars could be a promising option to help decrease healthcare costs and expand access to treatment. There is no previous evidence of a global bibliometric analysis on biosimilars. Therefore, we aimed to assess the quantity and quality of
Akram Hernández-Vásquez, Christoper A. Alarcon-Ruiz, Guido Bendezu-Quispe, Daniel Comandé, Diego Rosselli   +4 more
doaj   +1 more source

Efficacy and Safety of Biosimilar Romiplostim in Immune Thrombocytopenic Purpura : Single Centre Retrospective Data Analysis

Blood, 2020
Introduction: Thrombopoietin receptor agonist (TPO RA) is an approved second line of treatment in Persistent and Chronic Immune Thrombocytopenic Purpura (ITP).However in India due to cost constraints, the majority prefer Immunosuppression therapy.
S. Bhatwadekar, S. Deshpande, S. Khadse, Devashri Jani, Ujjwala Lakhmapurkar, Pina Vasoya, Saloni Shah, Aangi J. Shah, B. Shah, D. Desai   +9 more
semanticscholar   +1 more source

Capacity building in medicines development and regulation in Africa—Overview on recent progress

British Journal of Clinical Pharmacology, EarlyView.
Aims Despite advances in health research and digital innovation, many African countries continue to face substantial resource constraints, fragmented capacity‐building efforts and a shortage of skilled professionals in medicines development and regulatory science.
Tirhani Maluleke, Emile Malan, Michael Reid, Patrick Bouic, Haylene Nell, Goonaseelan Pillai, Catriona Waitt, Bernd Rosenkranz   +7 more
wiley   +1 more source