Original Research
Biosimilars naming, label transparency and authority of choice – survey findings among European physicians
Author(s): 1 Richard O Dolinar, MD, Michael S Reilly, Esq
Page: 58-62
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… Read More »
Perceptions of physicians from private medical centres in Malaysia about generic medicine usage: a qualitative study
Author(s): 1 Rohit Kumar, MPharm, 2 Mohamed Azmi Ahmad Hassali, PhD, 3 Navneet Kaur, PhD, Muhamad Ali SK Abdul Kader, MD
Page: 63-70
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,… Read More »
Alternative statistical strategies for biosimilar drug development
Author(s): 1 Austin J Combest, PharmD, MBA, 2 Song Wang, PhD, 3 Brian T Healey, PharmD, MS, MBA, RAC, 4 Dirk J Reitsma, MD
Page: 13-20
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… Read More »
Establishment of reference standards in biosimilar studies
Page: 173-7
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… Read More »
Assessing biosimilarity using the method of generalized pivotal quantities
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… Read More »
Regional tenders on biosimilars in Italy: potentially competitive?
Author(s): Alessandro Curto, MSSc, Katelijne Van de Vooren, MSc, Professor Livio Garattini, Roberta Lo Muto, MSc, Silvy Duranti, MBA
Page: 123-9
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… Read More »
Efficient production of recombinant parathyroid hormone (rPTH) fragment 1-34 in the methylotrophic yeast Hansenula polymorpha
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:… Read More »
How do regional sickness funds encourage more rational use of medicines, including the increase of generic uptake? A case study from Austria
Author(s): 1 Sabine Vogler, PhD, 2 Nina Zimmermann, MA
Page: 65-75
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… Read More »
Saving money in the European healthcare systems with biosimilars
Author(s): 1 Robert Haustein, 2 Christoph de Millas, 3 Ariane Höer, MD, 4 Professor Bertram Häussler, MD
Page: 120-6
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… Read More »