Results 11 to 20 of about 5,574 (244)

Policy measures and instruments used in European countries to increase biosimilar uptake: a systematic review

Frontiers in Public Health
IntroductionWhile biosimilar medicines can contribute to the sustainability of healthcare systems, their utilization rate varies across European countries.
Sara Machado, Agostinho Cruz, Pedro Lopes Ferreira, Pedro Lopes Ferreira, Carminda Morais, Carminda Morais, Rui Esteves Pimenta, Rui Esteves Pimenta   +7 more
doaj   +3 more sources

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

Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures? [PDF]

The European Journal of Health Economics, 2013
Biological medicines contain a biological substance that is produced by or derived from a living organism. The active substances of biologicals are usually larger and more complex than those of chemically derived medicines (non-biological medicine). Biologicals are used for the treatment of chronic and life-threatening diseases such as cancer, multiple
Farfan-Portet, María-Isabel, Gerkens, Sophie, Lepage-Nefkens, Isabelle, Vinck, Irmgard, Hulstaert, Frank   +4 more
openaire   +2 more sources

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

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

Generic Medicines and Biosimilars: Impact on Global Pharmaceutical Policy

, 2020
Patient access to safe and cost-effective treatment is an important goal for the healthcare system. The development of biosimilar compounds and generic medicines is interesting to the industry and society to reduce healthcare costs, fulfill the needs of healthcare stakeholders and potentially increase accessibility to patients.
Ibrahim, Mohamed Izham Mohamed, Awaisu, Ahmed.   +1 more
openaire   +3 more sources

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

Management of cancer-associated anemia with erythropoiesis-stimulating agents: ASCO/ASH clinical practice guideline update. [PDF]

, 2019
PURPOSE: To update the American Society of Clinical Oncology (ASCO)/American Society of Hematology (ASH) recommendations for use of erythropoiesis-stimulating agents (ESAs) in patients with cancer.
Bohlius, Julia, Bohlke, Kari, Castelli, Roberto, Djulbegovic, Benjamin, Lazo-Langner, Alejandro, Lustberg, Maryam B, Martino, Massimo, Mountzios, Giannis, Peswani, Namrata, Porter, Laura, Tanaka, Tiffany N., Trifirò, Gianluca, Yang, Hushan   +12 more
core   +3 more sources

Generics, Biosimilars, and the Ethics of Pricing Pharmaceuticals [PDF]

Journal of Veterinary Science & Medicine, 2016
Recent price hikes by pharmaceutical companies underscore the importance of competition in an industry that often sets prices according to what the market will bear. A steady pipeline of generics and biosimilars is the surest check to the rising prices of drugs and biologics.
openaire   +1 more source