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 as critical as monitoring for signs and symptoms of rheumatoid arthritis disease progression. With a focus on strengthening patient and provider education and engagement, patients…

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

biological therapy, patient engagement, pharmacovigilance, treatment response

DOI: 10.5639/gabij.2014.0301.008

Abstract: In South Africa, medicines are registered and regulated in terms of the Medicines and Related Substances Control Act (Act 101 of 1965), as amended, and the regulations to this Act. A guideline which outlines the quality, non-clinical and clinical requirements for the registration of a biosimilar medicine was first published in March 2012. This…

Author(s): Khamusi Philip Mutoti, BSc, BPharm Sci, Professor Nontombe Mbelle, MChB, MMed, FC Path (CMSA), Henry MJ Leng, PhD

biosimilars, comparative studies, registration requirements

DOI: 10.5639/gabij.2015.0403.033

Introduction/Study objective: This paper aims to survey the policies implemented by European countries for pricing and promoting the use of biosimilar medicines and to explore similarities and differences with policies for generic medicines. Methods: A literature review was supplemented by primary data collection with policymakers. Members of the Pharmaceutical Pricing and Reimbursement Information (PPRI) network,…

Author(s): Peter Schneider, MA, Sabine Vogler, PhD

biosimilar, generics, policy, pricing, substitution, tender

DOI: 10.5639/gabij.2017.0602.015

Author byline as per print journal: Shyam Akku, MD; Amit Garg, MD; Suhas Khandarkar, MPharm Introduction: Majority of the Colombian population has become health insured leading to improved healthcare access in the country. Healthcare expenses have risen drastically, and cancer is responsible for the major disease burden. An option to reduce cost burden is to replace…

Author(s): Amit Garg, MD, Shyam Akku, MD, Suhas Khandarkar, MPharm

anticancer drugs, cost-minimization, generics, pharmacoeconomics

DOI: 10.5639/gabij.2016.0504.042

Author byline as per print journal: Eleftheria Karampli, MSc; Estathia Triga, MSc; Vasiliki Tsiantou, MSc; Kostas Athanasakis, PhD; John Kyriopoulos, PhD Introduction/Study objectives: Generic medicines uptake is widely acknowledged as a key pharmaceutical policy measure towards cost containment and rational resource allocation. In Greece, due to the persistently low penetration of generics in the pharmaceutical…

Author(s): Eleftheria Karampli, MSc, Estathia Triga, MSc, John Kyriopoulos, PhD, Kostas Athanasakis, PhD, Vasiliki Tsiantou, MSc

generics, medicines consumption, patients, pharmaceutical policy, physicians, prescribing

DOI: 10.5639/gabij.2016.0501.005

Introduction/Study objectives: A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical products (FPPs). API manufacturers generally register API information as a Drug Master File (DMF) directly to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. Because DMFs require appropriate management by their registrants, it is important…

Author(s): Maki Matsuhama, MSc, Ryosuke Kuribayashi, PhD

active pharmaceutical ingredients, Drug Master File, generic drugs, globalization, stable supply

DOI: 10.5639/gabij.2018.0701.003

Abstract: Biosimilars have been available in Europe for more than 10 years, but their adoption in Germany has not been very successful. As their pharmaceutical quality, efficacy (particularly in extrapolated indications), safety (especially immunogenicity) and interchangeability with reference products have been controversially discussed by healthcare professionals, the Drug Commission of the German Medical Association developed…

Author(s): Professor Wolf-Dieter Ludwig, PhD, Stanislava Dicheva, PhD

biologicals, biosimilars, Germany, guidance, switching

DOI: 10.5639/gabij.2017.0604.037

Abstract:  Comment on the Letters to the Editor by Dr Carlo Petrini: A bioethicist’s view of the use of biosimilars, published in GaBI Journal, 2012, issue 3-4. Submitted: 9 November 2012; Revised: 12 November 2012; Accepted: 15 November 2012; Published online first: 19 November 2012 In GaBI Journal, 2012, issue 3-4, Dr Carlo Petrini [1] from the Italian National Institute of Health…

Author(s): Christian K Schneider, MD

DOI: 10.5639/gabij.2013.0201.001

Submitted: 4 March 2019; Revised: 25 April 2019; Accepted: 27 April 2019; Published online first: 30 April 2019 The availability of quality generic drug products plays an increasingly important role in promoting access to medicines worldwide and in helping to address rising healthcare costs. This, however, has led to significant pressures on medicines regulatory authorities…

Author(s): Alfredo García Arieta, PhD

DOI: 10.5639/gabij.2019.0801.005

Author byline as per print journal: Ali M Alhomaidan, PhD; Ibrahim A Aljuffali, MSc, PhD; Fahad S Alnutaifi, MHEcon, MPH; Nasseruddeen A AL-Howaimel, MSc Abstract: Innovation in the pharmaceutical industry is expensive and risk must be rewarded. Some novel pharmaceuticals may be worth their high prices. Yet, high prices may hinder accessibility to novel products.…

Author(s): Ali M Alhomaidan, PhD, Fahad S Alnutaifi, MHEcon, MPH, Ibrahim A Aljuffali, MSc,PhD, Nasseruddeen A AL-Howaimel, MSc

biosimilar, prices, Saudi Arabia

DOI: 10.5639/gabij.2016.0501.007

Abstract: A novel global and company specific biological qualifier, distinct from the International Nonproprietary Name (INN), is proposed by World Health Organization (WHO) for all biological active substances. Submitted: 14 May 2015; Revised: 2 July 2015; Accepted: 6 July 2015; Published online first: 20 July 2015 Introduction to INN The concept of one single non-proprietary…

Author(s): James S Robertson, PhD

biological active substances, Biological Qualifier (BQ), biosimilars, international non-proprietary names

DOI: 10.5639/gabij.2015.0403.025

Abstract: Hybridomas were developed in 1975 as a stable platform for creating monoclonal antibodies (mAbs). Over the past 40 years, hybridomas have been a leading platform for creating mAbs, yet of the 50 commercial mAbs approved for sale by the US Food and Drug Administration (FDA), only 18 are produced using hybridomas. Of the remainder,…

Author(s): Tim Steele, BS

hybridomas, microfluidics, monoclonal antibodies

DOI: 10.5639/gabij.2016.0501.006