Articles

Opinion

Published on 30 September 2013

Pathway to affordable, quality-assured sources of pegylated interferon alpha for treating hepatitis C

Author byline as per print journal: Barbara Milan, Sara Gaspani Introduction: The current pipeline of promising oral hepatitis C drugs could lead to a revolution in treatment for this disease...

Author(s): Barbara Milani, Sara Gaspani

biosimilars, competition, drug regulation, hepatitis C, pegylated interferon alpha, prices

DOI: 10.5639/gabij.2013.0204.053

37.282 views

Read more →

Editor's Letter

Published on 30 September 2013

Latest features in GaBI Journal, 2013, Issue 3

The GaBI Journal again contains manuscripts covering a wide range of pertinent topics. In an Editorial, Dr Gianluigi Casadei reviews Italy’s final position paper on biosimilars including the new price...

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0203.032

4.399 views

Read more →

Review Article

Published on 25 September 2013

Steps to ensure adequate supply of biological medicines: considerations for the healthcare provider

Author byline as per print journal: Andrew Mica, MBA, Martha Mutomba, PhD, Larry Green, PharmD Introduction: When drug shortages occur, healthcare providers (HCPs) often must ration drugs, cancel or delay...

Author(s): Andrew Mica, MBA, et al.

biological, drug shortages, healthcare provider, manufacturing, supply chain

DOI: 10.5639/gabij.2013.0203.038

41.807 views

Read more →

Perspective

Published on 06 August 2013

Assuring patient-centred care: engaging patients with rheumatoid arthritis in disease monitoring and pharmacovigilance

Abstract: With the advent of complex therapies in the form of biologicals, emerging biosimilars and non-biological complex drugs, monitoring for treatment related benefit and the potential for adverse effects is...

Author(s): Janet S Wyatt, RN, PhD, FAANP

biological therapy, patient engagement, pharmacovigilance, treatment response

DOI: 10.5639/gabij.2014.0301.008

16.496 views

Read more →

Regulatory

Published on 06 August 2013

US state legislation on biosimilars substitution

Abstract: Despite the fact that US Food and Drug Administration has yet to receive a biosimilars application, many US states have been considering legislation which could potentially limit biosimilars substitution....

Author(s): GaBI Journal Editor

biologicals, biosimilars substitution, state legislation

DOI: 10.5639/gabij.2013.0203.040

14.425 views

Read more →

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

16.661 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

5.039 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

189.764 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

12.660 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

28.287 views

Read more →