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…

Contents Editor's Letter What to look forward to in GaBI Journal, 2012, issue 2 Editorial Equal protection under the law: Children and the Best Pharmaceuticals for Children Act Regulatory Tighter EU rules on pharmacovigilance for biologicals Review Article What lessons can be learned from the launch of generic clopidogrel? Payers endorse generics to enhance prescribing…

Contents Editor's Letter Introduction to the GaBI Journal Editorial Generic medicine pricing: on track in Europe? Commentary Innovator companies should focus on innovations Review Article A review of generic medicine pricing in Europe Biologicals and biosimilars: a review of the science and its implications A patient-centred paradigm for the biosimilars market European payer initiatives to…

Abstract: The regulatory oversight of biologicals in Malaysia is established by the National Pharmaceutical Control Bureau (NPCB), Ministry of Health. At the agency, the Section on Biotechnology Product Registration exercises the marketing authorization function as the National Regulatory Authority (NRA). This paper provides an overview of the organization, regulatory expectations and current practices of the…

Author(s): Arpah Abas, BPharm, Yvonne Siew Khoon Khoo, BPharm (Hons) MMedSc, PhD (Pharmacology)

biologicals, evaluation, Malaysia, National Pharmaceutical Control Bureau (NPCB), regulation

DOI: 10.5639/gabij.2014.0304.044