Forthcoming Issue

Peer review articles planned or manuscripts submitted for peer review approval and publication in the forthcoming issues.

Online First

Online First articles have been peer reviewed, accepted for publication and published online; they have not yet been assigned to a journal issue. When an article is published in a journal issue with the assigned page number, it will be removed from the ‘Forthcoming Issue’ page.

Online First articles are copyedited by the science editors and the editorial production team; typeset, proofread and approved by the author(s) before publication. We aim to post each article within six weeks of acceptance and within two weeks after final proofreading approval by the author. Online First articles are in searchable full text, with the initial online publication date included in the final print version.

Articles appearing on the ‘Forthcoming Issue’ page are in the order of the Journal Editorial Sections.  You may also view the abstract by clicking on the article link.

Subscribe now to the print or PDF copy of GaBI Journal to view full information of the following manuscripts*.

Editor’s Letter

Fourth and final issue of GaBI Journal’s sixth volume/ Professor Philip D Walson, MD, USA/Germany

Letters to the Editor

Clear naming, traceability of biological medicines will protect patients /  Valderilio Feijó Azevedo, MD, PhD, MBA, Brian Bressler, MD, Alejandro Mercedes, MD

Comment on the non-biological complex drugs paper / Karthik Bodhinathan, PhD, MSM

Commentary

Global policies on pharmacy-mediated substitution of biosimilars: a summary / Thijs J Giezen, PharmD, PhD, MSc

Current overview of biosimilars in Iran / Hamideh Aghajani-Lazarjani, PhD; Fereidoun Mahboudi, PhD, Iran

Original Research

Pharmacy-mediated substitution of biosimilars – a global survey benchmarking country substitution policies / Hannah Larkin; Judith Macdonald; Rebecca Lumsden, PhD

Patient-reported outcome measures in phase III trials of LY2963016 insulin glargine and reference insulin glargine products: ELEMENT 1 and ELEMENT 2 / Puneet Kaushik,  Magaly Perez-Nieves, Robyn Pollom, Ran Duan, Samaneh Kalirai, Amy Delozier, Liza Ilag, India

Analysis of Drug Master Files Registered in Japan: For the Stable Supply of Active Pharmaceutical Ingredients / Maki Matsuhama, Ryosuke Kuribayashi, Japan

Assessing the perception and awareness of Maltese clinicians on biosimilars: where are we? / Louise Grech,PhD; Kathlene Cassar M.Sc; David Zammit Dimech, MD; Dustin Balzan, B.Pharm (Hons);  Anthony Cutajar, MSc; Paul John Cassar, MD, Malta

Bioequivalence study of two formulations of 60 mg daclatasivir in healthy volunteers / Sattam Turky AlGhodyyr, MSc;  Mohammad Khalil Mohammad, RPh., PhD; Sanabel Omar Dawabsheh; Mohammad Ali Abu Fara, MD; Majdi Naser Abu Al hajj; Rabab Fayyez Tayyem, PhD, Jordan

Assessment of medicine quality in emerging markets: the changing face of inferior medicines over time / Roger Bate, USA; Lorraine Mooney, UK

The assessment of biosimilarity with SABE and IBE criteria under a switching/alternating design / Aijing Zhang, PhD; Associate Professor Jung-Ying Tzeng; Professor Shein-Chung Chow, PhD, USA (Biosimilarity and Interchangeability)

Regulatory

Regulations for biosimilar approval in Colombia / Johanna Andrea García Cortes, MSc

Review Article

Major lessons learned from Zarxio’s US launch: the start of a biosimilar revolution / Michael Sarshad, USA

Generic immonusuppressants comparability studies / Marc Maliepaard, PhD; Professor Hubert G M Leufkens, PharmD, PhD, The Netherlands (Generic Immunosuppressants in Transplantation)

The impact of religion on human embryonic stem cell regulations: comparison between the UK, Germany and the US / Ali M Alhomaidan, PhD

Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: A story behind the evidence / O’Brien G, Carroll D, Mulcahy M, Walshe V, Courtney G, Byrne S

Protein heterogeneity and the immunogenicity of biotherapeutics / Professor Roy Jefferis, UK

Opinion

Generic immunosuppression in transplantation: a controversial analysis / Jacques Rottembourg, MD, France

Guidelines

Biosimilars in Germany: guidance of the Drug Commission of the German Medical Association / Professor Wolf-Dieter Ludwig, PhD; Stanislava Dicheva, PhD, Germany

Perspective

40th anniversary of essential medicines: a loud call for improving its access / Mohammad Bashaar, Professor Mohamed Azmi Hassali, Fahad Saleem

Special Report

Building stakeholder confidence in biosimilar medicines through evidence-based information sharing / Assistant Professor Gianluca Trifirò, MD, PhD, Italy

USA and Europe differ in interchangeability of biosimilars / Michelle Derbyshire, PhD, GaBI Online Editor

Patent expiry dates for biologicals: 2017 update / Michelle Derbyshire, PhD, GaBI Online Editor

Meeting Report

Perspectives on the future of pegfilgrastim biosimilars / Professor Pere Gascón, MD; Ruediger Jankowsky, PhD; Karsten Roth, PhD

INVIMA meetings strengthen knowledge of biosimilars in Colombia

Abstracted Scientific Content

Randomized non-inferiority trial fails to find inferiority switching from infliximab originator to CT-P13 biosimilar / Bea Perks, PhD, GaBI Journal Editor

A comparison of European and US generic drug markets / Maysoon Delahunty, GaBI Journal Editor

Barriers to generics policy reform: a US case study / Eleanor Bird, BSc (Hons), GaBI Journal Editor

Research News

HIV patients will accept generic treatments / Alice Rolandini Jensen, GaBI Journal Editor

Click here for more details on the educational series.

Contact us for an updated list of editorial topics in forthcoming issues.

*Editorial content may differ from final version of manuscript published in print.

Source URL: http://gabi-journal.net/gabi-journal/forthcoming-issue


Generics and Biosimilars Initiative (GaBI)
Tel: +32 474989572 | Fax: +32 14 583 048