Review Article

Statistical considerations for the development of biosimilar products

Published in: Volume 3 / Year 2014 / Issue 1
Author(s): ,
Page: 21-5

Abstract: As the patents of a growing number of biological medicines have already expired or are due to expire, it has led to an increased interest from both the biopharmaceutical… Read More »

Immunogenicity of biosimilar monoclonal antibodies

Published in: Volume 2 / Year 2013 / Issue 4
Author(s):
Page: 188-93.

Abstract: Biosimilar monoclonal antibodies (mAbs) are making their way onto the drug market. Because these are complex molecules in terms of structure and function, assessing similarity between originator and biosimilar… Read More »

Understanding the components of pharmaceutical expenditure—overview of pharmaceutical policies influencing expenditure across European countries

Published in: Volume 2 / Year 2013 / Issue 4
Author(s): , ,
Page: 178-87

Aim: To explain the components of pharmaceutical expenditure and illustrate the strengths and limitations of this indicator. In particular, we explore policies applied in European countries that affect the price… Read More »

Safety and toxicity of biosimilars—EU versus US regulation

Published in: Volume 2 / Year 2013 / Issue 3
Author(s): ,
Page: 144-50

Author byline as per print journal: Tobias Blank, PhD, Tilo Netzer, PhD, Wolfram Hildebrandt, MSc, MA, Angela Vogt-Eisele, PhD, Professor Marietta Kaszkin-Bettag, PhD Background: As patents for biological drugs begin… Read More »

Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider

Published in: Volume 2 / Year 2013 / Issue 3
Author(s): ,
Page: 136-43

Author byline as per print journal: Andrew Mica, MBA, Martha Mutomba, PhD, Larry Green, PharmD Introduction: When drug shortages occur, healthcare providers (HCPs) often must ration drugs, cancel or delay… Read More »

Pharmacokinetics of antimicrobials in obese children

Published in: Volume 2 / Year 2013 / Issue 2
Author(s): ,
Page: 76-81

Author byline as per print journal: Mario R Sampson, PharmD; Michael Cohen-Wolkowiez, MD, PhD; Professor Daniel Kelly Benjamin Jr, MD, MPH, PhD; Edmund V Capparelli, PharmD; Kevin M Watt, MD… Read More »

Biosimilars in the European market

Published in: Volume 2 / Year 2013 / Issue 1
Author(s): , , , , ,
Page: 30-5

Author byline as per print journal: Professor Joan Rovira, PhD; Leandro Lindner, BSc; Emmanuel Giménez, BSc; Professor Jaime Espín, PhD; Antonio Olry de Labry, PhD; Leticia García, BSc Introduction and… Read More »

Current status of biopharmaceuticals in Iran’s pharmaceutical market

Published in: Volume 2 / Year 2013 / Issue 1
Author(s):
Page: 26-9

Abstract: The clinical importance of biopharmaceuticals for the management of life threatening diseases is increasing but costs have become a major obstacle to the administration of these medicines, especially in… Read More »

Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act

Published in: Volume 2 / Year 2013 / Issue 1
Author(s): ,
Page: 20-5

Abstract: Biological (large molecule) drug products are made via living systems and are complex and variable in nature. As a result, generic forms of biological products, also termed biosimilars in… Read More »

Reference pricing systems in Europe: characteristics and consequences

Published in: Volume 1 / Year 2012 / Issue 3-4
Author(s): , ,
Page: 127-131

Author byline as per print journal: Pieter Dylst, PharmD; Professor Steven Simoens, MSc, PhD; Professor Arnold G Vulto, PharmD, PhD Introduction: A reference pricing system is a system that establishes a common reimbursement level… Read More »

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