Articles

Commentary

Published on 30 September 2013

Maximizing quality in the manufacture of biologicals

Abstract: Biological product quality is susceptible to unexpected manufacturing issues, and the resulting variation may impact the safety or efficacy of these medicines and increase risks to patients. These risks...

Author(s): Gustavo Grampp, PhD, Sundar Ramanan, PhD

biologicals, manufacturing, quality, safety

DOI: 10.5639/gabij.2013.0204.049

10.215 views

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Regulatory

Published on 30 September 2013

Comparison of biosimilars guidelines

Abstract: This paper provides a detailed comparison of biosimilars guidelines issued in Canada, the European Union, Japan and Korea; and by the World Health Organization (WHO). This comparison highlights the...

Author(s): GaBI Journal Editor

biosimilars, Canada, EU, guidelines, Japan, Korea, regulation, WHO

DOI: 10.5639/gabij.2014.0401.012

29.456 views

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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, price

DOI: 10.5639/gabij.2013.0204.053

37.005 views

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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

4.385 views

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Letters to the Editor

Published on 27 September 2013

WHO leadership in public safety on biosimilars to be commended

Abstract: As a practicing endocrinologist and Chairman of the Alliance for Safe Biologic Medicines, I am writing to commend the World Health Organization for its attention to and upcoming action...

Author(s): Richard O Dolinar, MD

biological identification, INN, public safety, WHO

DOI: 10.5639/gabij.2013.0204.047

10.602 views

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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

41.675 views

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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

16.402 views

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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

14.330 views

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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

16.573 views

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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

5.011 views

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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

189.689 views

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