Results 31 to 40 of about 5,547 (244)

Forced Degradation Testing as Complementary Tool for Biosimilarity Assessment [PDF]

, 2019
Oxidation of monoclonal antibodies (mAbs) can impact their efficacy and may therefore represent critical quality attributes (CQA) that require evaluation.
Dyck, Yan Felix Karl, Jabs, Wolfgang, Joseph, Jan Felix, Parr, Maria Kristina, Rehm, Daniel, Sandig, Volker, Winkler, Karsten   +6 more
core   +1 more source

Equivalence and switching between biosimilars and reference molecules in rheumatoid arthritis: protocol for a systematic review and meta-analysis

Systematic Reviews, 2021
Background Biologic drugs such as adalimumab, etanercept, and infliximab represent major first-line and second-line treatments for rheumatoid arthritis (RA) patients. However, their high cost poses a massive burden on healthcare systems worldwide.
Bruna O. Ascef, Matheus O. Almeida, Ana Cristina de Medeiros Ribeiro, Danieli C. O. Andrade, Haliton A. de Oliveira Júnior, Tiago V. Pereira, Patrícia C. de Soárez   +6 more
doaj   +1 more source

Knowledge and Viewpoints on Biosimilar Monoclonal Antibodies among Asian Physicians: Comparison with European Physicians

The Korean Journal of Gastroenterology, 2019
Background/Aims: Current knowledge and viewpoints regarding biosimilars among physicians in Asia are unknown, even though these were investigated by European Crohn’s and Colitis Organization (ECCO) members in 2013 and 2015.
Soo-Kyung Park, Won Moon, Eun Soo Kim, Sang Hyun Park, Dong Il Park   +4 more
doaj   +1 more source

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

Exploring drug cost and disease outcome in rheumatoid arthritis patients treated with biologic and targeted synthetic DMARDs in Norway in 2010–2019 – a country with a national tender system for prescription of costly drugs

BMC Health Services Research, 2022
Background In Norway, an annual tender system for the prescription of biologic and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) has been used since 2007. This study aimed to explore annual b/tsDMARDs costs and disease outcomes in
Alen Brkic, Andreas P. Diamantopoulos, Espen Andre Haavardsholm, Bjørg Tilde Svanes Fevang, Lene Kristin Brekke, Liz Loli, Camilla Zettel, Erik Rødevand, Gunnstein Bakland, Pawel Mielnik, Glenn Haugeberg   +10 more
doaj   +1 more source

Analysis of the Regulatory Science Applied to a Single Portfolio of Eight Biosimilar Product Approvals by Four Key Regulatory Authorities

Pharmaceuticals, 2021
Slow uptake of biosimilars in some regions is often attributed to a lack of knowledge combined with concerns about safety and efficacy. To alleviate physician and patient apprehensions, regulatory reviews from four major regulatory authorities (RAs ...
Beverly Ingram, Rebecca S. Lumsden, Adriana Radosavljevic, Christine Kobryn   +3 more
doaj   +1 more source

Evaluation of adverse events focusing on infection associated with infliximab originator and biosimilar using a spontaneous reporting system database

Journal of Pharmaceutical Health Care and Sciences, 2019
Background Infliximab (IFX) has changed the management of many life-threatening immune-mediated diseases. The high cost of IFX and its patent expiry have led to pharmaceutical companies developing a biosimilar; however, its safety profile remains unknown
Iku Niinomi, Keiko Hosohata, Yasuhiro Mori, Yuki Yamaguchi, Tomohito Wakabayashi, Mayako Uchida, Kazunori Iwanaga   +6 more
doaj   +1 more source

A Cure for All Ills? The Effectiveness of Therapeutic and Biosimilar Pharmaceutical Competition in the Netherlands

European Pharmaceutical Law Review, 2020
Ilan Akker, Wolf Sauter
openalex   +3 more sources

Economic aspects of biosimilar competition in Hungary — The treatment of rheumatic disorders [PDF]

, 2017
Biologicals are the fastest growing segment of the global pharmaceutical market, reaching 199 billion USD sales per year with 9.8% 10-year compound annual growth rate (CAGR).
Zrubka, Zsombor
core   +1 more source

The impact of the Medicines Control Council backlog and fast-track review system on access to innovative and new generic and biosimilar medicines of public health importance in South Africa [PDF]

, 2016
The fast-track registration policy of the South African National Department of Health allows for rapid registration of new medicines of public health importance and of all medicines on the Essential Medicines List, most of which are generics. No limit is
Leng, HMJ, Pollock, AM, Sanders, D
core   +3 more sources