Results 61 to 70 of about 7,770 (204)

Biosimilars

Journal of Infusion Nursing
Biologic drugs are large, complex molecules produced through biotechnology. A biosimilar is a biologic product that is highly similar to an already approved biologic (reference product), with no clinically meaningful differences in purity, safety, or efficacy; as such, a biosimilar does not need to undergo the same level of study in a clinical trial ...
Sheridan, Maria, Massich, Matthew, Ashourian, Nazanin   +2 more
  +6 more sources

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

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

Adverse Reactions Identified after Approval of Novel Medicines: Analysis of 339 New Molecular Entities and Therapeutic Biologics

Clinical Pharmacology &Therapeutics, EarlyView.
Postmarketing safety surveillance data identify safety issues not identified in preapproval clinical trials. We describe the frequency of new safety issues overall and by labeling section and the relationship of the most commonly added safety issues with the cumulative number of prescriptions dispensed via retail pharmacies.
Ellen Pinnow, Brendan Day, Esther H. Zhou, Corinne Woods, Nana Dwumfour, Jenni Y. Lee, Ilynn Bulatao, Sanae Cherkaoui, Manish Kalaria, Sonja Brajovic, Nabila Sadiq, Farideh Sistani, Maggie Lee, Grace Chai, Gerald Dal Pan   +14 more
wiley   +1 more source

Evaluation of rheumatologists’ knowledge of biosimilars

Advances in Rheumatology
Introduction Biosimilars reduce the cost of biologic therapy without compromising safety and effectiveness. In this study we evaluated Brazilian rheumatologists’ knowledge and perceptions of biosimilars.
Thayane Furtado Rolim Lima, Lia Poti Gomes Cordeiro, Kirla Wagner Poti Gomes, Carlos Ewerton Maia Rodrigues   +3 more
doaj   +1 more source

Policy Networks and Policy Entrepreneurship in the EU: Explaining Structural Policy Change in Pharmaceutical Innovation Incentives and Health Technology Assessment

European Policy Analysis, EarlyView.
ABSTRACT Policy process research has excelled in explaining structural policy change within national settings, but extensions and applications to the EU level have long proven challenging for scholars. Given that the EU is currently experiencing its longest period of Treaty stability since the 1980s—having evolved into a sui generis political system ...
Vassilis Karokis‐Mavrikos
wiley   +1 more source

The Efficiency of the German Healthcare System: Some Puzzling Findings

The International Journal of Health Planning and Management, EarlyView.
ABSTRACT This article examines the cost‐effectiveness of the German healthcare system from the perspective of statutory health insurance (SHI). Using data for 2011–2014—the most recent period for which consistent national inputs are available—we compare a marginal, system‐wide cost‐effectiveness ratio with the cost‐effectiveness of newly approved ...
Afschin Gandjour
wiley   +1 more source

Advances in Immunological Combination Therapy for Colorectal Cancer

iMetaMed, EarlyView.
Review the progress of combined immunotherapy for colorectal cancer. ABSTRACT Immune checkpoint inhibitors (ICIs) have been utilized extensively and shown to be therapeutically beneficial in the treatment of solid tumors in recent years. Nonetheless, considerable heterogeneity in Colorectal cancer (CRC) requires careful consideration.
Jiayue Wu, Rongbo Wen, Tianshuai Zhang, Fuao Cao, Xiaoming Zhu, Liqiang Hao, Wei Zhang, Guanyu Yu   +7 more
wiley   +1 more source

Proactive therapeutic drug monitoring of infliximab leads to treatment durability in paediatric Crohn's disease: A single‐centre Australian experience

JPGN Reports, EarlyView.
Abstract Objectives To evaluate the durability and predictors of loss of response of infliximab (IFX) over 2 years in paediatric Crohn's disease (CD) utilizing a proactive therapeutic drug monitoring (TDM) strategy. Methods A retrospective, single‐centre cohort study was conducted at The Children's Hospital at Westmead (CHW), Australia, from January ...
Cher Wei Chuah, Jessica Eldredge, Annabel Magoffin, Edward Vincent O'Loughlin, Calvin Joomann Park, Juliana Puppi, Susan Siew, Michael Stormon, Kunal Thacker, Shoma Dutt   +9 more
wiley   +1 more source

Outcomes of adalimumab biosimilar nonmedical switches in children and young adults with inflammatory bowel disease

JPGN Reports, EarlyView.
Abstract Objectives Adalimumab biosimilars are as safe and effective compared to the originator. Adult patients with inflammatory bowel disease (IBD) who switched to a biosimilar have comparable outcomes, but pediatric data are limited. This study evaluates clinical outcomes of children and young adults with IBD following a nonmedical, insurance‐driven
Daniel Himelstein, Megan McNicol, Mahmoud Abdel‐Rasoul, Brendan M. Boyle, Hilary K. Michel, Ross Maltz   +5 more
wiley   +1 more source