Introduction: A survey of the views of European physicians on familiarity of biosimilar medicines has demonstrated the need for distinguishable non-proprietary names to be given to all biologicals. Methods: The Alliance for Safe Biologic Medicines recruited 470 prescribers with clinical experience of biologicals in France, Germany, Italy, Spain and the UK to answer questions relating […]
Introduction: The healthcare sector is one of the most rapidly expanding and dynamic industries in the world. Pharmaceutical expenditure is now growing faster than other components of healthcare overheads. Globally, pressures to manage pharmaceutical spending have led to increased prescribing of generic drugs. Use of generic drugs in private medical centres in Malaysia, however, remains […]
Author byline as per print journal: Shon Crampton1, BA; Alla Polozova1, PhD; Darin Asbury2, BS; Alexis Lueras2, BS; Paul Breslin1, BS; Jane Hippenmeyer3, PharmD; Jennifer Litowski1, PhD; Monica Goss2, PhD Study objectives: To investigate the quality and in-use stability of diluted ABP 980 (a trastuzumab biosimilar) versus reference trastuzumab to mimic dosing in intravenous (IV) […]
Author byline as per print journal: Professor Jacques Rottembourg, MD; Corinne Emery, MSc; Alessandra Moglia, PhD Study objective: To describe and compare the haematological parameters and the anaemia medication use in haemodialysis patients who were switched from the originator iron sucrose (IS) to an iron sucrose similar (ISS). Methods: A retrospective observational single-centre study describing chronic […]
Introduction: Many regulatory authorities have published requirements for the approval of biosimilar medicinal products. However, there is no guidance on which quantitative standards should be used to define how similar a follow-on product must be to be considered biosimilar. Sample sizes for clinical biosimilar trials using traditional designs often exceed 500 patients. Several publications have […]
Author byline as per print journal: Aijing Zhang, PhD, Associate Professor Jung-Ying Tzeng, Professor Shein-Chung Chow, PhD Abstract: When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. In practice, however, important information on the innovative (reference) product may not be available for assessment. Thus, […]
Author byline as per print journal: Frank Mueller, MSc, Manal Moussa, MSc, Maria El Ghazaly, MSc, Jan Rohde, PhD, Nicole Bartsch, MSc, Antje Parthier, PhD, Frank Kensy, Dr Ing Background: Osteoporosis is a bone disease of the elderly that leads to increased risk of fracture. Currently, it affects more than 200 million adults worldwide, placing […]
Author byline as per print journal: Shih-Ting Chiu, PhD, Chen Chen, MSc, Professor Shein-Chung Chow, PhD, Eric Chi, PhD Introduction: For generic approval of small-molecule (chemical) drug products, US Food and Drug Administration requires evidence of equivalence in average bioavailability from bioavailability and bioequivalence studies. To address drug interchangeability, population bioequivalence (PBE) for drug prescribability […]
Author byline as per print journal: Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Roberta Lo Muto, MSc, Silvy Duranti, MBA, Professor Livio Garattini Introduction: Health care in Italy is mainly delivered through the country’s National Health Service (NHS), a public service funded by general taxation. The system is highly decentralized and each one of […]
Objective: To analyse similarities and differences between activities carried out by Austrian sickness funds to encourage more rational use of medicines, including increasing generics uptake. Methods: Semi-structured interviews with pharmacoeconomic unit staff of four regional sickness funds in Austria. Results: Sickness funds include a variety of activities. The main target group is prescribers, who are […]
Background: Due to the declining innovativeness of the classic R & D model in the original pharmaceutical industry, the generic pharmaceutical industry is aiming to become an innovation generator itself. Objective: The objective of this article is to gain insight into the re-innovation model in some of the innovative generic pharmaceutical firms. To this effect, […]
Introduction: The use of biotechnological manufactured drugs, or biologicals, has increased massively over the past few years. Used especially in the treatment of cancer and other severe diseases, biologicals incur high annual therapy costs and represent an additional burden for healthcare systems. Expenditure can be decreased by using cheaper biosimilars, produced following the patent expiration of […]
