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
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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
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
Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. [PDF]
, 2016 Biosimilars present a necessary and timely opportunity for physicians, patients and healthcare systems. If suitably developed clinically, manufactured to the correct standards and used appropriately, they can positively impact on the financial ...
Arnold, Dirk +19 more
core +5 more sources
Biosimilars; a unique opportunity for Iran national health sector and national pharmaceutical industry [PDF]
DARU Journal of Pharmaceutical Sciences, 2012 In 1980s, medicines produced through recombinant DNA technology created a novel opportunity for management of several debilitating and life threatening diseases. However, these medicines are very expensive and therefore not affordable for many patients especially those living in low resourced countries.
openaire +2 more sources
4CPS-008 Impact of pharmaceutical interview in patient acceptance of insulin glargine’s biosimilar 100UI/ml [PDF]
Section 4: Clinical Pharmacy Services, 2019 Background The insulin glargine’s biosimilar (IB) has been marketed since 2016, and is far less costly for the healthcare system, but their prescription is not yet predominant. To prescribe a biosimilar, the patient must be informed on what constitutes a biosimilar and must provide his agreement.
M Malassigné +5 more
openaire +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
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