Portuguese Position Paper on the Use of Biosimilars in Psoriasis [PDF]
Acta Médica Portuguesa, 2016 Keywords: Biological Agents; Biosimilar Pharmaceuticals; Portugal; Psoriasis/drug therapy.
Tiago Torres +15 more
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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 ...
Alexis Oliva, Matı́as Llabrés
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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
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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.
Mohamed Izham Mohamed Ibrahim +1 more
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Journal of Health Policy & Outcomes Research, 2014 Objectives: Review of the EU regulations concerning substitution of biological products with biosimilar products . Methods: The TPPC task force has checked the approach to automatic substitution by WHO, at the EMA level and in countries across European Union.
Mariola Drozd, Izabela Baran-Lewandowska
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Journal of Health Policy & Outcomes Research, 2013 Objectives: Due to the increased number in biosimilar drugs getting marketing authorization, there is a question to be answered which reimbursement procedure should be followed. Methods: The TPPC task force has checked the approach to biosimilar drugs by WHO, at the EMA level and in a few countries worldwide.
Mariola Drozd
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HPR96 Trends in European Pharmaceutical Tender Requirements and Opportunities for Differentiation for Biosimilars [PDF]
Value in Health, 2022 A Świder, P Borga, F Cousins
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Evolution of Biosimilar Medicines on the Romanian Pharmaceutical Market
Acta Pharmaceutica Hungarica, 2021 Emese Sipos +2 more
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Biosimilars Pharmaceutical Market in India: Current Status, Challenges and Future Perspective
Bioscience Biotechnology Research Communications, 2021 Ujalayan Gyan Prakash
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Key Regulatory Considerations for the Development of Biosimilar Pharmaceutical Products
IOSR Journal of Pharmacy (IOSRPHR), 2014 Samrat Sisodia Samrat Sisodia
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