Articles

Regulatory

Published on 24 April 2013

Biosimilar development and regulation in Japan

Abstract: In Japan, biosimilars guidelines following the principles of the EU framework were established by Japan’s Ministry of Health, Labor and Welfare in March 2009. The guidelines cover the manufacturing...

Author(s): GaBI Journal Editor

biosimilar, Japan, regulatory

DOI: 10.5639/gabij.2013.0204.055

17.059 views

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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, NBCD, similars

DOI: 10.5639/gabij.2013.0204.054

55.394 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

37.003 views

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Review Article

Published on 24 April 2013

Understanding the components of pharmaceutical expenditure—overview of pharmaceutical policies influencing expenditure across European countries

Aim: To explain the components of pharmaceutical expenditure and illustrate the strengths and limitations of this indicator. In particular, we explore policies applied in European countries that affect the price...

Author(s): Claudia Habl, Sabine Vogler, PhD, Nina Zimmermann, MA

health expenditures, hospital sector, medicine prices, pharmaceutical expenditure, policies, volume

DOI: 10.5639/gabij.2013.0204.051

63.045 views

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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

28.132 views

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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

10.213 views

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Letters to the Editor

Published on 12 November 2013

Biosimilars naming and prescribing policy in Australia

Submitted: 31 October 2013; Revised: 6 November 2013; Accepted: 11 November 2013; Published online first: 25 November 2013 To the Editor: I wanted to bring to your attention the following...

Author(s): Brendan Shaw, PhD

DOI: 10.5639/gabij.2013.0204.048

8.938 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

10.600 views

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Letters to the Editor

Published on 27 November 2013

Critical immunogenicity differences will be obscured by a common INN for biosimilars

Abstract: Information about variable immunogenicity arising from formulation differences between competing biosimilars is critical for informed judgments by prescribing physicians. Use of a common INN for biosimilars will obfuscate such...

Author(s): Edward T Maggio, PhD

immunogenicity, INN, neoantigen, neutralizing antibodies, oxidative damage, polysorbate, protein aggregation

DOI: 10.5639/gabij.2013.0204.046

6.330 views

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Letters to the Editor

Published on 29 October 2013

Legislative efforts to limit prescription information sharing between patients and healthcare providers represent a serious threat to the health and safety of the American nation

Abstract: Legislation in support of pharmacist notification to patients and providers of substitution of an interchangeable biologic for the originator biologic was recently vetoed in California. Automatic substitution of approved...

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

biologicals, patients, REMS

DOI: 10.5639/gabij.2013.0204.045

6.559 views

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Editorial

Published on 04 December 2013

Do low- to middle-income countries need a biosimilar approval pathway based on a full comparability exercise?

Abstract: Despite the fact that hepatitis C is a disease of global importance, many countries cannot afford the costly but effective combination treatment of peg-interferon and ribavirin, which was recently...

Author(s): Armando A Genazzani, DPhil, MD, Nicola Magrini, MD

alternative therapeutic products, biosimilar, essential medicines list, peginterferon, regulatory approval pathways, WHO

DOI: 10.5639/gabij.2013.0204.044

20.815 views

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