Results 41 to 50 of about 166 (149)

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

Health technology assessment of biosimilars worldwide: a scoping review

Health Research Policy and Systems, 2020
Background Health technology assessment (HTA) should provide an assessment of a technology’s effects on health and of the related social, economic, organisational and ethical issues. HTA reports on biosimilars can specifically assess their immunogenicity,
Bruna de Oliveira Ascef, Ana Carolina de Freitas Lopes, Patrícia Coelho de Soárez   +2 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

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

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

Rapid monitoring of health services use following a policy to switch patients from originator to biosimilar etanercept—a cohort study in British Columbia

BMC Rheumatology, 2022
Background Drug coverage policies that incentivize switching patients from originator to biosimilar products may result in significant health care savings. Our study aimed to detect early impacts on health services utilization following a mandated switch
Anat Fisher, Jason D. Kim, Greg Carney, Colin Dormuth   +3 more
doaj   +1 more source

External Control Arms in Japan: A Systematic Case Analysis of Documented Regulatory Implementation and Uncertainty Management

Clinical Pharmacology &Therapeutics, EarlyView.
External control arms (ECAs) have emerged as important tools to provide benchmark evidence on comparator effectiveness and thereby support regulatory decision making in situations where randomized controlled trials are difficult to conduct. However, how key methodological elements for ECAs are documented and implemented in practice and how residual ...
Suguru Okami, Alexandros Sagkriotis
wiley   +1 more source

Incidence of serious infection among etanercept and infliximab initiators: safety comparison between biosimilars and bio-originators with Canadian population-based data

BMC Rheumatology
Background Safety remains a significant concern for biologic drugs, and studies are needed to ensure a comparable safety profile for biosimilars and their legacy treatments.
Marina G. Birck, Luck Lukusa, Denis Choquette, Gilles Boire, Walter P. Maksymowych, Harminder Singh, Waqqas Afif, Sasha Bernatsky   +7 more
doaj   +1 more source

Administrative Databases and Diagnostic Therapeutic and Assistance Paths -PDTA- in the Monitoring Treatment of Rheumatoid Arthritis: The Experience of ATS Pavia

Pragmatic and Observational Research, 2023
Giacomo M Bruno,1,2 Maria Chiara Valentino,2 Alessandra Brunetti,3 Sergio Di Matteo,2 Ivan Begovic,2 Edoardo Croce,4 Garifallia Sakellariou,5 Serena Bugatti,6 Pietro Perotti,7 Silvia Vecchio,7 Simona Migliazza,7 Roberto Langella,8 Giorgio L Colombo1,2 ...
Bruno GM, Valentino MC, Brunetti A, Di Matteo S, Begovic I, Croce E, Sakellariou G, Bugatti S, Perotti P, Vecchio S, Migliazza S, Langella R, Colombo GL   +12 more
doaj