Abstract:  The International Conference on Harmonisation (ICH) has endorsed a new guideline concerning the development and manufacture of chemical and biotechnological/biological drug substances. The guideline harmonises the scientific and technical principles relating to the development and description of the drug substance manufacturing process to be included within the Common Technical Document (CTD) and submitted to…

Author(s): Keith McDonald, MSc, MRPharmS, Kowid Ho, PhD

biotechnological and chemical substances, drug substance quality, ICH Q11

DOI: 10.5639/gabij.2012.0103-4.025

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

Abstract: Although small molecule drugs still dominate the global pharmaceutical market in terms of numbers, biologicals are making a significant dent. However, the high cost of biologicals is putting increasing pressure on healthcare budgets, thus opening the door to biosimilars. With patents on originator biologicals expiring, biosimilars are expected to take an increasing share of…

Author(s): GaBI Journal Editor

biological, biosimilar, patent

DOI: 10.5639/gabij.2018.0701.007

Submitted: 19 June 2017; Revised: 5 September 2017; Accepted: 6 September 2017; Published online first: 19 September 2017 Introduction Comparative research on the European and US generic drug markets based on 2013 IMS data across 13 European countries with different generic drug policies has recently been accepted for publication in the Milbank Quarterly [1], and…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2017.0604.043

Author byline as per print journal: Professor Walter P Jeske, PhD; Jeanine M Walenga, PhD; Nicolas Simon, MD, PhD; Debra Hoppensteadt, PhD; Josephine Cunanan, MD; Vicki Escalante, BS; Jawed Fareed, PhD; Mamdouh Bakhos, MD Introduction: Low molecular weight heparins (LMWHs) are composed of a heterogeneous mixture of oligosaccharides that express a spectrum of biological activities. Studies…

Author(s): Debra Hoppensteadt, PhD, Jawed Fareed, PhD, Jeanine M Walenga, PhD, Josephine Cunanan, MD, Mamdouh Bakhos, MD, Nicolas Simon, MD, PhD, Vicki Escalante, BS, Professor Walter P Jeske, PhD

anticoagulation, generics, heparins, pharmacodynamics, pharmacokinetics, population

DOI: 10.5639/gabij.2015.0402.016

Abstract: Although not derived from living sources, non-biological complex drug (NBCD) products have the immunogenicity and molecular complexity of biological drugs. NBCDs typically contain heterogenous mixtures of closely related nanoparticulate components that cannot be isolated, quantified, or entirely characterized physicochemically. Development of follow-on versions of NBCDs poses many of the same scientific challenges associated with…

Author(s): J Michael Nicholas, PhD

follow-on drugs, glatiramoids, iron-carbohydrate complexes, liposomes, non-biological complex drug (NBCD)

DOI: 10.5639/gabij.2014.0302.020

Author byline as per print journal: Valderilio Feijó Azevedo, MD, PhD; Eduardo Mysler, MD; Alexis Aceituno Álvarez, PharmD, PhD; Juana Hughes, MSc; Francisco Javier Flores-Murrieta, PhD, FCP; Eva Maria Ruiz de Castilla, MS, MAA, PhD Abstract: With the emergence of biosimilars as a new class of biotherapeutic agents, the use of these products in Latin America has become a focus…

Author(s): Alexis Aceituno Álvarez, PharmD, PhD, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Eduardo Mysler, MD, Eva Maria Ruiz de Castilla, MS, MAA, PhD, Francisco Javier Flores-Murrieta, PhD, FCP, Juana Hughes, MSc

biological products, biosimilarity, biosimilars, Latin America, reference biotherapeutic product (RBP), regulatory pathways

DOI: 10.5639/gabij.2014.0303.032

Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Meenu Wadhwa, PhD Abstract:  Biosimilars are firmly established in the EU as copy biologicals with a clear and effective regulatory route for approval. Unfortunately, inconsistency in nomenclature for biosimilars has caused confusion. This problem of terminology has been the subject of a recent publication. The confusion is…

Author(s): Meenu Wadhwa, PhD, Robin Thorpe, PhD, FRCPath

comparability, guidelines, non-innovator biologic, quality, safety

DOI: 10.5639/gabij.2012.0103-4.023

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 need for harmonization of global regulatory standards for the approval of biosimilars. Biosimilars are recognized around the world as safe and effective medicines. Despite this…

Author(s): GaBI Journal Editor

biosimilars, Canada, EU, guidelines, Japan, Korea, regulation, World Health Organization (WHO)

DOI: 10.5639/gabij.2014.0401.012

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 an application for regulatory approval of biosimilar products. In practice, however, important information on the innovative (reference) product may not be available for assessment. Thus,…

biosimilarity, biosimilarity index, highly similar, reference standards, replicate reference study

DOI: 10.5639/gabij.2013.0204.050

Abstract:  Trade in falsified/counterfeit medical products is a growing global criminal industry, posing a major threat to patients and healthcare systems. Falsified/Counterfeit medical products circulate via unregulated channels, especially the Internet. The Council of Europe’s ‘Convention on counterfeiting of medical products and similar crimes involving threats to public health’ [1] is the first international treaty…

Author(s): Susanne Keitel, MD

Council of Europe, counterfeit medicines, criminalization, falsified medicines, international treaty, MEDICRIME Convention

DOI: 10.5639/gabij.2012.0103-4.029

Abstract: Cancer represents a significant, and growing, burden on healthcare systems. This is driven, at least in part, by escalating cancer drug budgets. Loss of patent protection on biopharmaceuticals enables the development and production of similar biological medicines, or biosimilars. Biosimilars are currently available for use in oncology in the supportive care setting; the focus…

Author(s): Matti Aapro, MD

biosimilars, cost burden, oncology

DOI: 10.5639/gabij.2013.0202.023