Results 71 to 80 of about 790,096 (261)

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

Implementation and use of risk minimization control tools in the EU: A multistakeholder survey

British Journal of Clinical Pharmacology, EarlyView.
Aims This study characterized stakeholders' experiences with national implementation of risk minimization control tools (RMCTs), such as healthcare professional qualification, healthcare facility accreditation and medical intervention prior to treatment initiation, for eight medicinal products across eight European Union countries. Methods We conducted
Sharon C. M. Essink, Iris R. Joosse, Maximilian Salcher‐Konrad, Melanie Walter, Elena Deligianni, Dimitra Tsioumela, Christos Kontogiorgis, Elita Poplavska, Iluta Žīgure, Christina E. Hoeve, Teresa Leonardo Alves, Ella D. van Vliet, Renato Ferreira‐da‐Silva, Ana Kodrič, Mitja Kos, Juan Erviti, Marta Gutiérrez‐Valencia, Luis Carlos Saiz, Sofia Kälvemark Sporrong, Emelie Karlsson, Christine Leopold, Marie L. De Bruin   +21 more
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  

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

Cell and Gene Therapies Manufacturing Challenges and Integrated Good Manufacturing Practices Solutions: A Lifecycle Perspective

Biotechnology and Bioengineering, EarlyView.
Lifecycle perspective on cell and gene therapy manufacturing challenges and enabling GMP solutions. ABSTRACT Cell and gene therapies (CGTs) are revolutionizing modern medicine; however, making these advanced medicines scalable and readily available to commercial manufacturers worldwide is a major challenge. The number of approved CGT products continues
Rajath Samaga, Udisha Singh, Sachin Dattram Pawar   +2 more
wiley   +1 more source

Biosimilar Drugs for Multiple Sclerosis: An Unmet International Need or a Regulatory Risk?

Neurology and Therapy, 2019
Multiple sclerosis (MS) more than any other neurological disorder has experienced a tremendous progress in available evidence-based innovator disease modifying therapies (DMT).
Victor M. Rivera
doaj   +1 more source

Perceptions towards biologic and biosimilar therapy of patients with rheumatic and gastroenterological conditions

BMC Rheumatology, 2022
Background Biologic and targeted synthetic disease modifying agents (b/tsDMARDs) have broadened the treatment landscape for autoimmune diseases particularly in patients refractory to conventional DMARDs. More recently, the introduction of biosimilars has
Thomas Khoo, Navkiran Sidhu, Franca Marine, Susan Lester, Alannah Quinlivan, Debra Rowett, Rachelle Buchbinder, Catherine L. Hill   +7 more
doaj   +1 more source

Heterogeneity in learning processes and the evolution of dynamic managerial capabilities as a response of emergence of biosimilar market: evidence from the Indian pharmaceutical industry [PDF]

Technology Analysis & Strategic Management, 2017
This paper examines heterogeneity in the response of Indian firms to the emergence of a new segment in the pharmaceutical generics market – biosimilars. The necessary diversity of the knowledge base and regulatory requirements underlying biosmilar products have created significant technological capability and market access challenges for Indian firms ...
Dinar Kale, Farah Huzair
openaire   +1 more source

Analysis of Suffix Use for Biosimilar Product Identification in Postmarketing Adverse Event Reporting

Clinical Pharmacology &Therapeutics, EarlyView.
Accurate identification of medicines used in adverse event reports is crucial for effective postmarketing safety surveillance. The US Food and Drug Administration's (FDA) four‐letter suffix naming convention was designed to facilitate accurate biological product identification, but the extent to which these suffixes have been incorporated into ...
Danijela Stojanovic, Lisa Wolf, M. Stacey Ricci, Monica A. Muñoz   +3 more
wiley   +1 more source