Study objectives: In Latin America, many governments have attempted to address biosimilar safety and efficacy concerns by developing abbreviated regulatory pathways to increase access while controlling quality. This study explores discount and evidence requirements for payers and physicians to provide access to and prescribe biosimilars in Argentina, Brazil and Mexico. Methods: We conducted targeted literature…

Author(s): , André Vidal Pinheiro, PhD, Daniele Severi Bruni, MPhil, Ronald Halbert, MD, MPH, Erik Sandorff, MA, MBA

biosimilar pharmaceuticals, discounts, drug industry, Latin America, prescribing

DOI: 10.5639/gabij.2015.0401.005

Abstract: Notwithstanding the scientific and regulatory differences between generic and biosimilar medicines, the European Medicines Agency/Committee for Medicinal Products for Human Use has consistently applied a ‘same active substance’ approach to both. Submitted: 28 November 2014; Revised: 20 January 2015; Accepted: 27 January 2015; Published online first: 30 January 2015 It is often stated that…

Author(s): Barbara J van Zwieten-Boot, Marcel Hoefnagel, Peter MJM Jongen, R Martijn van der Plas

active substance, biosimilar, EMA, Europe, guidelines, regulatory

DOI: 10.5639/gabij.2015.0401.004

Abstract: Dr Brian Godman reviews the paper by Vogler and co-authors on the procurement of generics or originators among European hospitals once multiple sources become available. Submitted: 28 November 2014; Revised: 3 December 2014; Accepted: 3 December 2014; Published online first: 16 December 2014 Vogler and co-authors have provided valuable insight into the procurement of…

Author(s): Brian Godman, BSc, PhD

Europe, generics, hospitals, procurement

DOI: 10.5639/gabij.2014.0304.037

Abstract: Biotech giant Amgen now has a biosimilars programme that includes nine different molecules. A representative from Amgen has spoken to GaBI about the company’s venture into biosimilars. Topics included how to encourage the use of biosimilars and how a Japanese example of biosimilars uptake can help Europe in increasing use of biosimilars. Submitted: 25…

Author(s): GaBI Journal Editor

biosimilar, naming, uptake

DOI: 10.5639/gabij.2014.0304.048

Abstract: Australia currently has a small generic and biosimilar medicine industry despite having a good track record in biomedical research and a sound reputation in producing high quality but small volume biological pharmaceuticals. In recent times, Australia has made incremental changes to its regulation of biosimilars – in patent registration, in the use of commercial…

Author(s): David Lim, DPH

Australia, biosimilars, confidential information, patent, regulation, remuneration

DOI: 10.5639/gabij.2014.0304.042

The world market for medicinal products is expected to reach US$1 trillion in 2014. Global spending on medicines is expected to grow to nearly US$1.2 trillion by 2017 [1]. As governments around the world try to rein in healthcare expenses, generics and biosimilars can play a major role in reducing this budgetary burden. Intellectual property…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2014.0304.046

Abstract: The attractiveness of the biosimilar regulatory pathway is threatened by so-called biobetters. This paper provides definitions and an overview of recent developments. Submitted: 27 October 2014; Revised: 7 November 2014; Accepted: 12 November 2014; Published online first: 25 November 2014 Concerning the biosimilar landscape, the European Medicines Agency (EMA) was among the first institutions…

Author(s): René Anour, DVM

biobetter, biosimilar, competition, interchangeability, regulatory pathways

DOI: 10.5639/gabij.2014.0304.039

Contents Editor’s Letter Latest features in GaBI Journal, 2014, Issue 3 Editorial Regional regulatory processes for the approval of biosimilars; differences and similarities Original Research Barriers to market uptake of biosimilars in the US Retrospective chart review: disrupted anaemia control in haemodialysis patients following the switch to an iron sucrose similar (ISS) after long-term treatment…

Contents Editor's Letter What to look forward to in GaBI Journal, 2014, Issue 2 Editorial Complex molecules – current developments Commentary Defining and characterizing nonbiological complex drugs (NBCDs) – Is size enough? The case for liposomal doxorubicin generics (‘liposomal nanosimilars’) for injection Original Research Biosimilars naming, label transparency and authority of choice – survey findings…

Contents Editor's Letter Editor’s introduction to the initial issue of the third volume of GaBI Journal Editorial Drug shortages hit US oncologists hard Letters to the Editor Common or distinct INN for biosimilars? Only characteristics of the active substance prior to formulation should be considered Commentary Biosimilar monoclonal antibodies approved for use in the EU…

Contents Editor's Letter GaBI Journal publishes four issues in 2013 Editorial Suggested evaluation of biological drugs role for WHO – Editor’s response Do low- to middle-income countries need a biosimilar approval pathway based on a full comparability exercise? Letters to the Editor Legislative efforts to limit prescription information sharing between patients and healthcare providers represent…

Contents Editor's Letter Latest features in GaBI Journal, 2013, Issue 3 Editorial Italy’s final position paper on biosimilars and new price and reimbursement pathway Commentary Commentary on the recommendations of the European Society for Organ Transplantation Advisory Committee on generic substitution of immunosuppressive drugs Biosimilar monoclonal antibodies—challenges and opportunities in Europe Ongoing initiatives in the…