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 on the important issue of non-proprietary names for biotech medicines. Submitted: 20 September 2013; Revised: 21 September 2013; Accepted: 21 September 2013; Published online first:…

Author(s): Richard O Dolinar, MD

biological identification, INN, public safety, World Health Organization (WHO)

DOI: 10.5639/gabij.2013.0204.047

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 differences to the detriment of patients. Submitted: 31 October 2013; Revised: 12 November 2013; Accepted: 13 November 2013; Published online first: 26 November 2013 Immunogenicity…

Author(s): Edward T Maggio, PhD

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

DOI: 10.5639/gabij.2013.0204.046

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 biosimilars without notifying the patient and physician/healthcare provider circumvents important pharmacovigilance. Submitted: 21 October 2013; Revised: 22 October 2013; Accepted: 25 October 2013; Published online…

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

biologicals, patients, REMS

DOI: 10.5639/gabij.2013.0204.045

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 included in the World Health Organization Essential Medicines List. Given that peg-interferon is a biotechnological product, should low- to middle-income countries adopt the burdensome biosimilar…

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

alternative therapeutic products, biosimilar, essential medicines, peginterferon, regulatory approval pathways, World Health Organization (WHO)

DOI: 10.5639/gabij.2013.0204.044

Abstract: The Editor-in-Chief expresses his concerns about the proposal of a WHO run system to approve copy biologicals in the Milani and Gaspani paper [1]. The paper by Milani and Gaspani [1] suggests that the World Health Organization (WHO) sets up a programme to approve follow-on pegylated interferons and similar biological medications, that is biological…

Author(s): Professor Philip D Walson, MD

biological products, pegylated interferons, World Health Organization (WHO)

DOI: 10.5639/gabij.2013.0204.043

Editor's Letter

Published on 05 December 2013

GaBI Journal publishes four issues in 2013

This issue marks the forth and final issue of the second year’s edition of the GaBI Journal. The journal has grown rapidly through the combined efforts of the publisher and her staff, all of the members of the executive editorial board and the international editorial advisory board, our contributors, advertisers and readers for which I…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0204.042

The approval of biosimilars in the European Union (EU) is governed by the EU biosimilar framework released in 2004. But new arrivals on the biosimilar stage – monoclonal antibodies – are forcing regulatory authorities to reconsider what constitutes a biosimilar, writes Dr Ebbers and co-authors [1]. Many monoclonal antibodies (mAbs) will lose patent protection in…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2013.0203.041

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. The Biologics Price Competition and Innovation Act (BPCI Act) of 2009 was signed into law on 23 March 2010 by President Barack Obama. The BPCI…

Author(s): GaBI Journal Editor

biologicals, biosimilars substitution, state legislation

DOI: 10.5639/gabij.2013.0203.040

Abstract: Some years ago, Australian regulatory authorities decided to follow the path laid down by the European Medicines Agency in adopting a process for approval of biosimilars. This has been a largely successful process, resulting in the licensing of biosimilars for many peptides, especially epoetin and granulocyte colony-stimulating factor (G-CSF). Aside from the availability of…

Author(s): Professor David A Power, MD, PhD, FRCP, FRACP

Australia, biosimilars, pharmaceutical benefits scheme, TGA

DOI: 10.5639/gabij.2013.0203.030

Author byline as per print journal: Tobias Blank, PhD, Tilo Netzer, PhD, Wolfram Hildebrandt, MSc, MA, Angela Vogt-Eisele, PhD, Professor Marietta Kaszkin-Bettag, PhD Background: As patents for biological drugs begin to expire, the need for scientific guidance on biosimilar drugs grows increasingly important. The European Medicines Agency provided the first guidelines to cover the approval…

Author(s): Angela Vogt-Eisele, PhD, Professor Marietta Kaszkin-Bettag, PhD, Tilo Netzer, PhD, Wolfram Hildebrandt, MSc, MA, Tobias Blank, PhD

biosimilar regulation, biosimilar safety (EU USA), biosimilar toxicity, immunogenicity, pharmacovigilance, traceability

DOI: 10.5639/gabij.2013.0203.039

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 treatments, or utilize alternative drugs that may be less efficacious and/or are associated with increased risk of adverse outcomes, potentially impacting patient care. The likelihood…

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

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

DOI: 10.5639/gabij.2013.0203.038

Author byline as per print journal: Shih-Ting Chiu, PhD, Chen Chen, MSc, Professor Shein-Chung Chow, PhD, Eric Chi, PhD Introduction: For generic approval of small-molecule (chemical) drug products, US Food and Drug Administration requires evidence of equivalence in average bioavailability from bioavailability and bioequivalence studies. To address drug interchangeability, population bioequivalence (PBE) for drug prescribability…

Author(s): et al., Shih-Ting Chiu, MSc

extra-reference design, generalized pivotal quantity, individual bioequivalence, replicated crossover design

DOI: 10.5639/gabij.2013.0203.037