Original Research
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 »
European prescribers’ attitudes and beliefs on biologicals prescribing and automatic substitution
Author(s): Madelaine A Feldman, MD, FACR, Michael S Reilly, Esq
Page: 116-24
Introduction: The European Union (EU) and the European Medicines Agency (EMA) have led the development of a regulatory framework for biosimilars since 2004. By end of December 2019, 64 biosimilars… Read More »
Pharmacokinetic bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology — risk assessment and mitigation using GastroPlus software
Author byline as per print journal: Dhananjay Panigrahi1, MPharm; Aditya Murthy2, MPharm, PhD; Shubham Jamdade2, MPharm; Manoj Gundeti2, MPharm; Nagarjun Rangaraj1, MPharm, PhD; Anup Avijit Choudhury1, MPharm; Tausif Ahmed2, MPharm,… Read More »