Articles

Editorial

Published on 05 August 2013

Italy’s final position paper on biosimilars and new price and reimbursement pathway

Abstract: The AIFA’s position paper recognizes the relevance of biosimilars to ensure the sustainability of drug expenditure but the new price and reimbursement procedure may not favour their prompt market...

Author(s): Gianluigi Casadei, MD

AIFA, biosimilars, market access, position paper, pricing, reimbursement

DOI: 10.5639/gabij.2013.0203.033

16.618 views

Read more →

Editor's Letter

Published on 03 July 2013

What to look forward to in GaBI Journal, 2013, Issue 2

The first of two Letters to the Editor is from Ms Gaspani and Ms Milani expressing their concerns about the lack of clear regulatory guidelines for approval of liposomal generic...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0202.028

5.026 views

Read more →

Editorial

Published on 12 June 2013

National and regional activities by sickness funds in Austria to encourage the rational use of medicines

Abstract: Dr Brian Godman reviews the paper by Vogler and Zimmermann on sickness fund activity in Austria to preferentially encourage the prescribing of generics. This is particularly important given the...

Author(s): Brian Godman, BSc, PhD

Austria, demand-side measures, generics, sickness funds

DOI: 10.5639/gabij.2013.0202.026

189.722 views

Read more →

Commentary

Published on 12 June 2013

Ongoing initiatives in the Republic of Srpska to enhance prescribing efficiency; influence and future directions

Abstract: Dr Brian Godman reviews the paper by Markovic-Pekovic et al. regarding recent reforms in the Republic of Srpska. These include prescribing restrictions where concerns with the value of products...

Author(s): Brian Godman, BSc, PhD

demand-side measures, generics, renin-angiotensin inhibitor drugs, Srpska, statins, supply-side measures

DOI: 10.5639/gabij.2013.0203.029

12.640 views

Read more →

Original Research

Published on 11 June 2013

Establishment of reference standards in biosimilar studies

Author byline as per print journal: Aijing Zhang, PhD, Associate Professor Jung-Ying Tzeng, Professor Shein-Chung Chow, PhD Abstract: When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file...

biosimilarity, biosimilarity index, highly similar, reference standards, replicate reference study

DOI: 10.5639/gabij.2013.0204.050

28.202 views

Read more →

Special Report

Published on 11 June 2013

A progress report on the 3rd International Symposium on Scientific and Regulatory Advances in Biological and Non-Biological Complex Drugs: A to Z in Bioequivalence

Author byline as per print journal: Jon SB de Vlieger1, PhD; Professor Daan JA Crommelin2, PhD; Beat Flühmann3, PhD; Professor Imre Klebovich4, PharmD, PhD, DSc; Professor Stefan Mühlebach3,5, PhD; Vinod...

Author(s): Beat Flühmann, PhD, Daan JA Crommelin, Imre Klebovich, Jon SB de Vlieger, PhD, Professor Stefan Mühlebach, PhD, Vinod P Shah, PhD

biological medicinal products, equivalence, nanomedicines, NBCD similar approach, non-biological complex drug (NBCD)

DOI: 10.5639/gabij.2019.0803.016

10.274 views

Read more →

Original Research

Published on 11 June 2013

Efficient production of recombinant parathyroid hormone (rPTH) fragment 1-34 in the methylotrophic yeast Hansenula polymorpha

Author byline as per print journal: Frank Mueller, MSc, Manal Moussa, MSc, Maria El Ghazaly, MSc, Jan Rohde, PhD, Nicole Bartsch, MSc, Antje Parthier, PhD, Frank Kensy, Dr Ing Background:...

Author(s): et al., Frank Mueller, MSc

fermentation, hansenula polymorpha, parathyroid hormone fragment, recombinant protein, rPTH 1-34

DOI: 10.5639/gabij.2013.0203.035

21.919 views

Read more →

Review Article

Published on 28 May 2013

The need for distinct nomenclature for originator and biosimilar products

Author byline as per print journal: Michael Sarshad, BSc, MBA; Rosanne Campbell, BComm, PGdip, MSc; Peter J Pitts, BA; Jacqueline anderpuye- Orgle, MSc, PhD Abstract: As the number of biosimilar...

Author(s): Jacqueline Vanderpuye-Orgle, MSc, PhD, Michael Sarshad, BSc, MBA, Rosanne Campbell, BComm, PGdip, MSc, Peter J Pitts, BA

biosimilars, Inflectra, International Nonproprietary Name (INN), naming, nomenclature, Zarxio

DOI: 10.5639/gabij.2018.0704.031

8.499 views

Read more →

Guidelines

Published on 06 May 2013

Update on clinical practice guideline on the use of epoetin and darbepoetin in adult patients with cancer

Abstract: Chemotherapy-induced anaemia can be treated using erythropoiesis-stimulating agents (ESAs), but these can cause serious side-effects including tumour progression, venous thromboembolism, and shorter survival. Following extensive review of recent literature,...

Author(s): GaBI Journal Editor

chemotherapy-induced anaemia, darbopoetin, epoetin, erythropoetin-stimulating agents, haemoglobin, thromboembolism

DOI: 10.5639/gabij.2013.0202.018

6.662 views

Read more →