Review Article
Tyrosine kinase inhibitors becoming generic drugs – risks and chances from a regulatory perspective
Author(s): Bodo Haas, PhD, Christoph Unkrig, MD, Frauke Naumann-Winter, PhD, Harald Enzmann, MD, Henrike Potthast, PhD, Lea Röper, BSc, Niels Eckstein, PhD, Ulrike Hermes, PhD
Page: 79-87
Author byline as per print journal: Niels Eckstein, PhD; Lea Röper, BSc; Bodo Haas, PhD; Henrike Potthast, PhD; Ulrike Hermes, PhD; Christoph Unkrig, MD; Frauke Naumann-Winter, PhD; Harald Enzmann, MD Aim: To provide a systematic overview on: i)… Read More »
Clinical development, immunogenicity, and interchangeability of follow-on complex drugs
Abstract: Although not derived from living sources, non-biological complex drug (NBCD) products have the immunogenicity and molecular complexity of biological drugs. NBCDs typically contain heterogenous mixtures of closely related nanoparticulate… Read More »
Statistical considerations for the development of biosimilar products
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
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
Author(s): 1 Sabine Vogler, PhD, 2 Nina Zimmermann, MA, Claudia Habl
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
Author(s): 1 Tobias Blank, PhD, Angela Vogt-Eisele, PhD, Professor Marietta Kaszkin-Bettag, PhD, Tilo Netzer, PhD, Wolfram Hildebrandt, MSc, MA
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
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
Author(s): 1 Mario R Sampson, PharmD, et al.
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
Author(s): Antonio Olry de Labry, PhD, Emmanuel Giménez, BSc, Leandro Lindner, BSc, Leticia García, BSc, Professor Jaime Espín, PhD, Professor Joan Rovira, PhD
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
Author(s): Professor Abdol Majid Cheraghali, PharmaD, PhD
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 »