Results 31 to 40 of about 18,044 (238)

Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines [PDF]

, 2018
Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations to identify challenges ...
Anvisa, Castaneda-Hernandez, CBER, CBER, CBER, CBER, CBER, CBER, CBER, CDSCO, CFDA, Christl, Cofepris, Gautam, Lozda, MCC, Minghetti, Olech, Priori, Rushvi, Schiestl   +20 more
core   +5 more sources

Biosimilarity assessment of biosimilar therapeutic monoclonal antibodies

Drug Metabolism and Pharmacokinetics, 2019
The concept of biosimilar was established in the early 2000s in EU. Currently, the regulatory framework for biosimilar has also been established in the US, Japan, and other countries. As of 2018, biosimilars for infliximab, adalimumab, rituximab, trastuzumab, and bevacizumab have been approved.
Akiko, Ishii-Watabe, Takashi, Kuwabara
openaire   +2 more sources

Did the Introduction of Biosimilars Influence Their Prices and Utilization? The Case of Biologic Disease Modifying Antirheumatic Drugs (bDMARD) in Bulgaria

Pharmaceuticals, 2021
The aim of this study is to evaluate the effect of the introduction of biosimilars in Bulgaria on the prices and utilization of biologic disease modifying antirheumatic drugs (bDMARD).
Konstantin Tachkov, Zornitsa Mitkova, Vladimira Boyadzieva, Guenka Petrova   +3 more
doaj   +1 more source

Tumor necrosis factor inhibitors in psoriatic arthritis. [PDF]

, 2017
INTRODUCTION: Psoriatic arthritis (PsA) is a chronic inflammatory disease that can result in significant disability. With the emergence of tumor necrosis factor inhibitors (TNFi), therapeutic outcomes in PsA have improved substantially.
Kraft, Walter K., Mantravadi, Santhi, Ogdie, Alexis   +2 more
core   +2 more sources

Tendering and biosimilars: what role for value-added services?

Journal of Market Access & Health Policy, 2020
Background: Access to biologic medicines (including biosimilars) across Europe is largely governed by a process of tendering conducted by health authorities. Over-reliance on treatment costs in awarding tenders has the potential to hinder competition and
Steven Simoens, Raymond Cheung
doaj   +1 more source

Comparative Effectiveness of Biosimilar, Reference Product and Other Erythropoiesis-Stimulating Agents (ESAs) Still Covered by Patent in Chronic Kidney Disease and Cancer Patients: An Italian Population-Based Study [PDF]

, 2016
Background Since 2007 biosimilars of erythropoiesis-stimulating agents (ESAs) are available on the Italian market. Very limited post-marketing data exist on the comparative effectiveness of biosimilar and originator ESAs.
Alibrandi, A. (Angela), Bolcato, J. (Jenny), Caputi, A.P. (Achille), Chinellato, A. (Alessandro), Fontana, A. (Andrea), Genazzani, A.A. (Armando A.), Giorgianni, F. (Francesco), Ientile, V. (Valentina), Ingrasciotta, Y. (Ylenia), Marcianò, I. (Ilaria), Pirolo, R. (Roberta), Santoro, D. (Domenico), Trifirò, G. (Gianluca)   +12 more
core   +6 more sources

Biosimilars for the treatment of patients with psoriasis: A consensus statement from the Biosimilar Working Group of the International Psoriasis CouncilCapsule Summary

JAAD International, 2020
Background: As biosimilars have become available in various parts of the world, the International Psoriasis Council has reviewed aspects of their use.
Arnon D. Cohen, MD, MPH, PhD, Ronald Vender, MD, FRCPC, Luigi Naldi, MD, Robert E. Kalb, MD, Tiago Torres, MD, PhD, Murlidhar Rajagopalan, MD, Joelle van der Walt, PhD, Lluís Puig, MD (Hon), PhD, Helen S. Young, MB ChB, PhD, FRCP   +8 more
doaj   +1 more source

Real‐world trends in prenatal antirheumatic drug utilization in Ontario, Canada: A cross‐sectional time‐series analysis

Arthritis Care &Research, Accepted Article.
Objectives This study aimed to describe real‐world trends in preconception and prenatal use of antirheumatic drugs among pregnant individuals with rheumatic diseases in Ontario, Canada. Methods We conducted a time‐series analysis using repeated cross‐sectional data to examine annual patterns of disease‐modifying antirheumatic drug (DMARD) use among ...
Shenthuraan Tharmarajah, Swaleh Hussain, Sara J.T. Guilcher, Lisa M. McCarthy, Dharini Mahendira, Howard Berger, Mina Tadrous   +6 more
wiley   +1 more source

An open-label, randomized study comparing lipegfilgrastim with filgrastim in pediatric patients receiving chemotherapy for Ewing sarcoma or rhabdomyosarcoma

Scientific Reports
This study compared efficacy and safety of lipegfilgrastim with filgrastim in pediatric patients. Children and adolescents receiving chemotherapy (4 cycles) for Ewing sarcoma or rhabdomyosarcoma were randomized 1:1 to lipegfilgrastim (100 µg/kg) once per
Margarita B. Belogurova, Andreas Lammerich, Hadas Barkay, Dayoung Seo, Anton Buchner   +4 more
doaj   +1 more source

Biosimilars in the French and Polish System: Chosen Aspects of Reimbursement and Access

Comparative Economic Research, 2020
The EU approved the first biosimilar drug in 2006. By 2017, the EU had authorized the highest number of biosimilars worldwide, acquiring considerable experience in their use and safety.
Olga Barszczewska, Ralph Chami, Anna Piechota   +2 more
doaj   +1 more source