Results 51 to 60 of about 11,407 (242)

Biosimilar medicines uptake: The role of the clinical pharmacist

Exploratory Research in Clinical and Social Pharmacy, 2021
The introduction of biological medicines has revolutionized the management of chronic diseases. Due to the high cost of biological medicine coupled with the fact that patents of many of these medicines are on the verge of expiration, manufacturers are ...
Roland Nnaemeka Okoro
doaj   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Can local policies on biosimilars optimize the use of freed resources – experiences from Italy [PDF]

, 2020
There is an increasing need to prescribe biosimilars to fund new medicines and increasing medicine volumes.
Allocati, Eleonora, Godman, Brian, Kwon, Hye-Young, Moorkens, Evelien   +3 more
core  

Safety of switching between rituximab biosimilars in onco-hematology

Scientific Reports, 2021
Comparable clinical efficacy and safety of the reference rituximab (MABTHERA) and its biosimilars has been established in randomized trials. However, safety concerns are often raised when switching from reference to biosimilar products and between ...
Silvana A. M. Urru, Stefania Spila Alegiani, Anna Guella, Giuseppe Traversa, Annalisa Campomori   +4 more
doaj   +1 more source

Biologics and biosimilars

Journal of Dermatological Treatment, 2015
Biological drugs are large, complex glycoprotein molecules produced in living organisms. Revolutionary treatments for many conditions, biologics used in dermatology will face patent expiration, opening opportunities for competitive versions. Biologic drugs are so complex such that it is impossible to reproduce them exactly.
Palak K, Patel, Caleb R, King, Steven R, Feldman   +2 more
openaire   +2 more sources

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

Biosimilars: Science, Implications, and Potential Outlooks in the Middle East and Africa

Biologics: Targets & Therapy, 2022
Radwa Ahmed Batran,1 Mai Elmoshneb,1 Ahmed Salah Hussein,1,2 Omar M Hussien,1 Fady Adel,1 Reham Elgarhy,1 Mosaad I Morsi1 1Medical Affairs Department, RAY Contract Research Organization, Giza, Egypt; 2Faculty of Medicine, Al-Azhar University, Cairo ...
Batran RA, Elmoshneb M, Hussein AS, Hussien OM, Adel F, Elgarhy R, Morsi MI   +6 more
doaj  

The challenge of biosimilars

Annals of Oncology, 2008
The purpose of this report was to review issues associated with the introduction of alternative versions of biosimilars used in the oncology setting.Data were obtained by searches of MEDLINE, PubMed, references from relevant English-language articles, and guidelines from the European Medicines Agency.When biosimilars are approved in EU, they will be ...
H, Mellstedt, D, Niederwieser, H, Ludwig
openaire   +2 more sources

Exploring individualized crovalimab dosing in PNH through in silico modelling: Potential for improved convenience and cost efficiency

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Paroxysmal nocturnal haemoglobinuria (PNH) is a rare, acquired haematopoietic stem cell disorder. Crovalimab, a complement C5‐inhibitor, is approved for PNH and can be self‐administered subcutaneously every 4 weeks, offering a more convenient route than intravenous C5‐inhibitors.
Mendy ter Avest, Simon E. Koele, Nicole C. A. J. van de Kar, Saskia M. C. Langemeijer, Rob ter Heine   +4 more
wiley   +1 more source

Biosimilars for Rheumatoid Arthritis: Riding the 2023 Wave [Podcast]

, 2023
Stanley B Cohen,1,* Mariah Z Leach2,* 1Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas, USA; 2Mamas Facing Forward, Louisville, Colorado, USA*These authors contributed equally to this ...
Cohen SB, Leach MZ
core