Results 31 to 40 of about 681,456 (227)
Health Economics, 2021 Previous studies have estimated that patients served by health systems accrue 59‐98% of the value generated by new pharmaceuticals. This has led to questions about whether sufficient returns accrue to manufacturers to incentivize socially optimal levels ...
B. Woods +3 more
semanticscholar +1 more source
Purification Process of a Recombinant Human Follicle Stimulating Hormone Biosimilar (Primapur®) to Yield a Pharmaceutical Product with High Batch-to-Batch Consistency [PDF]
Pharmaceutics, 2022 Recombinant human follicle stimulating hormone (r-hFSH) is widely used for infertility treatment and is subject to the development of biosimilars. There are different purification strategies that can yield r-hFSH of pharmaceutical quality from Chinese hamster ovary cell culture broth.
Maria Sinegubova +6 more
openaire +3 more sources
Fine Chemical Technologies, 2021 Objectives. In this biosimilar research, we compare the monoclonal antibody eculizumab obtained from different drugs [original Soliris® (Alexion Pharmaceuticals) and candidate Elizaria® (Generium)] by intact mass measurement and middle-up mass ...
M. Degterev, R. Shukurov
semanticscholar +1 more source
Biosimilar Agents for Psoriasis Treatment: The Perspective of Portuguese Patients
Acta Médica Portuguesa, 2018 Introduction: Biosimilars are highly similar copies of previously approved original biologic medicines. Their introduction on the market may yield cost reduction.
Alexandra Azevedo +3 more
doaj +1 more source
Biosimilar tenecteplase versus alteplase in acute ischemic stroke: A real world study
Annals of Indian Academy of Neurology, 2023 Background and Purpose: There is an unmet need for a more effective thrombolytic agent in acute ischemic stroke (AIS) management. Various studies and meta-analysis suggest tenecteplase (TNK) as non-inferior over alteplase (rTPA).
Ayush Mohan +11 more
doaj +1 more source
Medicines under additional monitoring in the European Union [PDF]
Farmacia Hospitalaria, 2019 Objective: The objective of this study was to analyse the characteristics of medicines subject to additional monitoring. We assessed the following aspects: the criteria applied to approve a medicine as being subject to additional monitoring; the ...
Esther Salgueiro +5 more
doaj +1 more source
Validation of a Size-Exclusion Chromatography Method for Bevacizumab Quantitation in Pharmaceutical Preparations: Application in a Biosimilar Study [PDF]
Separations, 2019 In May 2019, the Food and Drug Administration (FDA) proposed a quality range (QR) method for the comparative analytical assessment in biosimilar studies. In this process, several reference product lots are necessary, selected from a wide period of manufacturing dates with different shelf lives, to calculate the total variability expressed as the ...
Oliva Martín, Alexis Manuel +1 more
openaire +3 more sources
Ars PharmaceuticaRESUMEN Objetivo: Determinar los aspectos esenciales de la reglamentación de Costa Rica referente al registro sanitario de biosimilares y compararlos con la información brindada en los dosieres de laboratorios fabricantes de heparina y enoxaparina ...
Rebeca Álvarez Brenes +3 more
doaj +1 more source
Frontiers in Pharmacology, 2022 Although rituximab is widely used off-label for complex pediatric diseases, safety reports are limited. We aimed to report evidence of its use in clinical practice, to describe the incidence of adverse drug reactions (ADR) to rituximab biosimilar Novex ...
Natalia Riva +20 more
doaj +1 more source
Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries
Frontiers in Pharmacology, 2017 Objectives: The aim of this study was to review the requirements for the reimbursement of biosimilars and to compare the reimbursement status, market share, and reimbursement costs of biosimilars in selected Central and Eastern European (CEE) countries ...
Paweł Kawalec +11 more
doaj +1 more source