Submitted: 31 October 2013; Revised: 6 November 2013; Accepted: 11 November 2013; Published online first: 25 November 2013 To the Editor: I wanted to bring to your attention the following paper which was published in Volume 2/Year 2013/Issue 3 of the Generics and Biosimilars Initiative Journal. The Perspective paper titled Licensing and prescribing biosimilars in…

Author(s): Brendan Shaw, PhD

DOI: 10.5639/gabij.2013.0204.048

The approval of biosimilars in the European Union (EU) is governed by the EU biosimilar framework released in 2004. But new arrivals on the biosimilar stage – monoclonal antibodies – are forcing regulatory authorities to reconsider what constitutes a biosimilar, writes Dr Ebbers and co-authors [1]. Many monoclonal antibodies (mAbs) will lose patent protection in…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2013.0203.041

Submitted: 17 November 2017; Revised: 20 November 2017; Accepted: 22 November 2017; Published online first: 5 December 2017 The tumour necrosis factor (TNF) inhibitor infliximab is known to significantly improve the treatment of inflammatory autoimmune diseases such as Crohn’s disease, ulcerative colitis and rheumatoid arthritis. The high cost of biological originators, however, has meant that…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.042

Author byline as per print journal: Steven Kozlowski1, MD; Ellen Tworkoski2, MS, MPhil; Carmen Dekmezian2, MS; Yanchang Zhang2, MPH; Natasha Flowers2, BA; Alvin So3, MS; Andreas M Schick3, PhD; Michael Wernecke2, BA; Thomas MaCurdy2,4, PhD; Jeffrey A Kelman5, MD, MMSc Background: Drug pricing and availability are key concerns for reducing healthcare costs and meeting patient…

Author(s): Jeffrey A Kelman, MD, MMSc, Steven Kozlowski, MD, Ellen Tworkoski, MS, MPhil, Carmen Dekmezian, MS, Yanchang Zhang, MPH, Natasha Flowers, BA, Alvin So, MS, Andreas M Schick, PhD, Michael Wernecke, BA, Thomas MaCurdy, PhD

generic drugs, pharmacy, US Medicare

DOI: 10.5639/gabij.2019.0803.013

Author byline as per print journal: Stephen P Murby, FRSA; Michael S Reilly, Esq Introduction: As the number of biosimilar approvals in Australia increases, it is important to build on the existing regulatory framework to continue to bring high quality, safe and efficacious biosimilars to the widest number of patients most cost-effectively. As new policies regarding…

Author(s): Michael S Reilly, Esq, Stephen P Murby, FRSA

Australia, biologicals, labelling, naming, prescribers

DOI: 10.5639/gabij.2017.0603.022

Author byline as per print journal: Ali M Alhomaidan, PhD; Mohammed Abdulaziz Alageel, MSc; Turki Abdulaziz Alrafie, MSc; Hassan Mohammed Alqarni, MSc; Ibraheem Yahya Khbrani, MSc; Dalal J Alkhamis, MSc; Mohammed F Alkhalifah, MSc; Abdualmajeed S bin Jumaiah, MSc; Mohammed A Dahhas, PhD Abstract: The Saudi Food and Drug Authority’s (SFDA) pharmaceutical products approval and…

Common Technical Documents, drug regulation, good manufacturing practice, Saudi FDA

DOI: 10.5639/gabij.2023.1203.013

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Eleonora Allocati4, BSc, MSc; Evelien Moorkens5, BSc, MSc Abstract: Siu et al. comprehensively assessed the rapidly changing regulation and reimbursement environment for biologicals and biosimilars in Canada and the resultant implications. The current situation in Canada is compared with similar initiatives across different countries to…

Author(s): Brian Godman, BSc, PhD, Eleonora Allocati, BSc, MSc, Evelien Moorkens, BSc, MSc

biologicals, biosimilars, Canada, policy, regulation, savings

DOI: 10.5639/gabij.2019.0803.012

Abstract: Despite biopharmaceuticals having an enormous potential value for our health, they have also become a serious threat to our healthcare systems. Submitted: 22 June 2011; Revised manuscript received: 6 October 2011; Accepted: 11 October 2011 Recombinant drugs, or biologicals as they are widely termed, are highly complex drug substances that have added tremendous treatment…

Author(s): Professor Theodor Dingermann, PhD

DOI: 10.5639/gabij.2012.0101.003

Author byline as per print journal: Professor John-Joseph Borg, PhD; Yolanda Elias Gramajo, MD; Professor Andrea Laslop, MD; Robin Thorpe, PhD, FRCPath; Jian Wang, MD, PhD Introduction: Biosimilars have the potential to improve access to medicines for many across the globe. However, work is required to ensure adequate regulation, pharmacovigilance and education about biosimilars. Colombia…

Author(s): Jian Wang, MD, PhD, Professor Andrea Laslop, MD, Professor John-Joseph Borg, Robin Thorpe, PhD, FRCPath, Yolanda Elias Gramajo, MD

biologicals, biosimilars, Colombia, INVIMA

DOI: 10.5639/gabij.2020.0903.022

Abstract: Biosimilar products confront novel market authorization and post-marketing use hurdles. Existing evidence is insufficient to fully address physician and payer acceptability thresholds. Submitted: 4 March 2015; Revised: 5 March 2015; Accepted: 9 March 2015; Published online first: 20 March 2015 In this issue of GaBI Journal, Sandorff et al. [1] investigate payer and physician…

Author(s): Professor Alan Lyles, BSPharm, MPH, ScD, PhD (h.c.)

acceptability, biologicals, biosimilars, interchangeability, pricing

DOI: 10.5639/gabij.2015.0401.002

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Eleonora Allocati4, BSc, MSc; Evelien Moorkens5, MSc, PhD; Hye-Young Kwon, PhD1,6 Abstract: There is an increasing need to prescribe biosimilars to fund new medicines and increasing medicine volumes. Bertolani and Jommi document successful measures introduced regionally in Italy. The recent GaBI Journal manuscript by Bertolani…

Author(s): Brian Godman, BSc, PhD, Eleonora Allocati, BSc, MSc, Evelien Moorkens, BSc, MSc, Hye-Young Kwon, BPharm, MPH, PhD

biosimilars, demand-side measures, educational initiatives, Italy, savings

DOI: 10.5639/gabij.2020.0904.029

Author byline as per print journal: Chuei Wuei Leong1, PhD; Elton Sagim1, BBiomedSc, Kar Ming Yee1, BPharm; Muhammad Shalhadi Saharuddin1, BSc; Sharifah Radziah Syed Abd Rahim1, MSc; Khairil Sabri1, BSc; Mohd Zulhairi Jamaluddin1, BSc; Shahnun Ahmad1, MBBS; Atiqah Amran1, BSc; Rabab F Tayyem2, PhD Introduction/Study Objectives: The present study aimed to evaluate the comparative bioavailability…

bioequivalence, new branded generics, sitagliptin hydrochloride, sitagliptin phosphate

DOI: 10.5639/gabij.2023.1201.004