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…

Contents Editor's Letter What to look forward to in GaBI Journal, 2013, Issue 2 Editorial National and regional activities by sickness funds in Austria to encourage the rational use of medicines Letters to the Editor Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx Challenges to generic medicines utilization in Yemeni healthcare system Original Research…

Contents Editor's Letter Editor’s introduction to the wide range of topics in the initial issue of the second volume of GaBI Journal Letters to the Editor The ethics of biosimilars Austria increases dialogue in order to involve physicians more with biosimilars Editorial Health authority perspective on biosimilars Commentary The case for biosimilars–a payer’s perspective Original…

Contents Editor's Letter Latest features in GaBI Journal, 2012, issue 3-4 Letters to the Editor A bioethicist’s view of the use of biosimilars A clinician’s view of the ethics of the use of biosimilars Editorial Generics policies–a globally-relevant implementation challenge Reference price systems: stakeholder dialogue and involvement Commentary Statin generics: no differences in efficacy after…