Abstract: This paper discusses the findings and summary of items covered in the First Turkish interactive workshop on regulation and approval of similar biotherapeutic products/biosimilars, in which structure–function was highlighted as a key issue. Submitted: 4 June 2016; Revised: 7 September 2016; Accepted: 15 September 2016; Published online first: 28 September 2016 Introduction This interactive…

Author(s): Professor Philip D Walson, MD, Robin Thorpe, PhD, FRCPath

glycosylation, immunogenicity, potency, receptor binding, serum half-life, sialic acid

DOI: 10.5639/gabij.2016.0503.034

Abstract: Biological molecules represent a significant portion of therapies utilized in Canada. Biosimilars, also known as subsequent entry biologics (SEBs) in Canada, are highly comparable versions of the originator products. Over the next few years, a number of patents for innovator biologicals will expire in Canada and this creates a tremendous opportunity for the entrance…

Author(s): Eric CK Siu, MSc, PhD, George Wyatt, BSc, MBA

biosimilars, CADTH, Canada, CDR, pCODR, subsequent entry biologics (SEBs)

DOI: 10.5639/gabij.2016.0503.028

Abstract: The role of sound science, discovery, and innovation in value-added pharmaceuticals has not been sufficiently considered. This term is mainly used to define improved version of generic drugs. The concept of value-added pharmaceuticals has been picked up by different groups of companies, some are aiming to increase willingness to pay for their modified pharmaceutical…

Author(s): Fereshteh Barei, PhD

competitive advantage, generic pharmaceuticals, innovation, value-added pharmaceuticals

DOI: 10.5639/gabij.2016.0504.044

Author byline as per print journal: Babar Khan, BPharm, MPH, PhD; Brian Godman, BSc, PhD; Ayesha Babar, BPharm, MPhil; Shahzad Hussain, BPharm, MPhil; Sidra Mahmood, PharmD, MSc; Tahir Aqeel, BPharm, MPhil Introduction: There are concerns over the quality of generic medicines in Pakistan. This is due to perceived non-compliance with good manufacturing practice (GMP), whereby the…

Author(s): Ayesha Babar, BPharm, MPhil, Babar Khan, BPharm, MPH, PhD, Brian Godman, BSc, PhD, Shahzad Hussain, BPharm, MPhil, Sidra Mahmood, PharmD, MSc, Tahir Aqeel, BPharm, MPhil

API (active pharmaceutical ingredient), Drugs Regulatory Authority, generics, ibuprofen, Pakistan

DOI: 10.5639/gabij.2016.0504.041

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Eleonora Allocati4, BSc, MSc; Evelien Moorkens5, BSc, MSc Abstract: Siu et al. comprehensively assessed the rapidly changing regulation and reimbursement environment for biologicals and biosimilars in Canada and the resultant implications. The current situation in Canada is compared with similar initiatives across different countries to…

Author(s): Brian Godman, BSc, PhD, Eleonora Allocati, BSc, MSc, Evelien Moorkens, BSc, MSc

biologicals, biosimilars, Canada, policy, regulation, savings

DOI: 10.5639/gabij.2019.0803.012

Contents Editor’s Letter What to look forward to in GaBI Journal, 2016, Issue 2 Editorial Adjusted indirect comparisons between generics – bioequivalence and interchangeability Review Article Assessment of the interchangeability between generics  Legal Biosimilars patent litigation in Canada and Japan: a comparative strategic overview and EU and US update Perspective New monoclonal antibody biosimilars approved…

Submitted: 30 June 2016; Revised: 1 July 2016; Accepted: 1 July 2016; Published online first: 4 July 2016 The European Medicines Agency’s (EMA) decision to approve the use of CPT-13, an infliximab biosimilar, in the treatment of inflammatory bowel disease (IBD), has proven controversial. In two papers, Professor Fernando Gomollón [1, 2] has reviewed and…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0502.022

Abstract: The development of biological medicinal products is in rapid growth and as patents for reference products expire, new biosimilar products become available. This has a marked impact on several stakeholders; from patients and physicians to decision-makers, and on activities; from treatment of patients to the conduct of pharmacovigilance. The Danish Medicines Agency (Laegemiddelstyrelsen, DKMA)…

Author(s): Benedicte Lunddahl, DVM

biological medicinal products, biosimilars, national competent authority, pharmacovigilance

DOI: 10.5639/gabij.2016.0503.030

Editor's Letter

Published on 04 July 2016

What to look forward to in GaBI Journal, 2016, Issue 2

This second issue of 2016 includes manuscripts that cover a number of important issues of interest to GaBI Journal including methods used to assess bioequivalence and decide on interchangeability, patient and advocacy group opinions concerning the use of follow-on products, batch-to-batch consistency in monoclonal antibody production, and the causes and potential ways to deal with the…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2016.0502.013

Author byline as per print journal: Federico Fontolan1, MA; Silvia Zucconi1, MStat; Carlo Piccinni2, PhD Abstract: In this paper, an overview is provided of the present Italian generic medicines system. Data on generic medicines market share and enterprise performance were reviewed and discussed, and the results of a survey completed by general practitioners (Computer Assisted…

Author(s): Carlo Piccinni, PhD, Federico Fontolan, MA, Silvia Zucconi, MStat

economic sustainability, generic medicines, manufacturing provision, pharmacoeconomics

DOI: 10.5639/gabij.2016.0503.029

Author byline as per print journal: Professor Paul J Declerck, PhD; Paul W Tebbey, PhD Abstract: The clinical performance of biological therapies is affected by their manufacturing processes. The advent of biosimilars increases the need to understand the clinical impact of potential differences versus originator products. This paper reviews important recently published technical data on…

Author(s): Paul W Tebbey, PhD, Professor Paul J Declerck, PhD

adalimumab, biosimilar pharmaceuticals, consistency, glycosylation, immunogenicity, manufacturing

DOI: 10.5639/gabij.2016.0502.018

Author byline as per print journal: Niklas Ekman, PhD; Professor Arnold G Vulto, PharmD, PhD; Paul Cornes, MD Abstract: The increasing cost of medicines was highlighted at the Biosimilar Medicines Group (formerly EBG) satellite symposium at the European Association of Hospital Pharmacists’ 2016 Vienna conference. Using biosimilars as a way to reduce pharmaceutical expenditure was…

Author(s): Niklas Ekman, PhD, Paul Cornes, MD, Professor Arnold G Vulto, PharmD, PhD, FCP

biological, biosimilar, cancer, European Union, healthcare costs, medicines, regulatory

DOI: 10.5639/gabij.2016.0502.020