Articles

Meeting Report

Published on 30 September 2013

The authorization of non-biological complex drugs (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead?

Author byline as per print journal: Professor Stefan Mühlebach, PhD, Professor Arnold Vulto, PharmD, PhD, Jon SB de Vlieger, PhD, Vera Weinstein, PhD, Beat Flühmann, PhD, Vinod P Shah, PhD...

Author(s): Beat Flühmann, PhD, Jon SB de Vlieger, PhD, Professor Arnold G Vulto, PharmD, PhD, FCP, Professor Stefan Mühlebach, PhD, Vera Weinstein, PhD, Vinod P Shah, PhD

glatiramoids, iron sucrose, liposomes, nanomedicines, non-biological complex drug (NBCD), similars

DOI: 10.5639/gabij.2013.0204.054

55.453 views

Read more →

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

10.234 views

Read more →

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

37.048 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

4.390 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

41.702 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

16.428 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

14.358 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

16.590 views

Read more →