Biosimilars are biological drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety and efficacy. Biosimilar epoetin received US Food and Drug Administration (FDA) approval in 2018 [1]. The manufacturer received an FDA non-approval letter in 2017, despite receiving a favourable review by the FDA’s Oncologic Drugs Advisory…

DOI: 10.5639/gabij.2021.1003.015

Author byline as per print journal: Pieter J Glerum1,2, MSc; Mert Hayta1,3, PharmD, MSc; David M Burger4, PharmD, PhD; Cees Neef5, PharmD, PhD; Marcel L Bouvy3, PharmD, PhD; Marc Maliepaard1,6, PhD Background: Drug switching describes switching between drug products with the same active substance. Drug switching occurs commonly in the Netherlands and mostly between generic drug…

Brand-name drugs, drug switching, generic drugs, generics substitution, interchangeability, pharmacy practice

DOI: 10.5639/gabij.2021.1003.014

Author byline as per print journal: Nishalini Harikrishnan1, BSc; Ka-Liong Tan2, DPhil; Kar Ming Yee3, BPharm; Alia Shaari Ahmad Shukri1, MSc; Nalla Ramana Reddy4, MBBS; Chuei Wuei Leong3, PhD Introduction/Study Objectives: A bioequivalence study was performed to compare the pharmacological profile of innovator etoricoxib (ETO) with a newly developed generic ETO, both in a 120…

bioequivalence, COX-2 inhibitor, etoricoxib, generics

DOI: 10.5639/gabij.2021.1003.013

Editor's Letter

Published on 29 September 2021

Latest features in GaBI Journal, 2021, Issue 3

This issue of GaBI Journal contains articles dealing with some very practical issues related to the evaluation, describing, and use of generic and biosimilar products. These issues include the uncertainty associated with extrapolating results of studies that used small, non-representative study populations, study sites, or product types. These problems are evident in the evaluation of…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2021.1003.012

Submitted: 15 March 2021; Revised: 17 March 2021; Accepted: 18 March 2021; Published online first: 24 March 2021 Cancer is one of the leading causes of mortality in the world today. The development of new drugs can reduce death rates, but these products are extremely expensive in terms of development time and money. This has…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2021.1002.011

Author byline as per print journal: Farhang Rezaei, PharmD; Nassim Anjidani, PharmD Background: The advent of follow-on biologicals in Iran and biosimilars worldwide have provided various treatment options for several severe and chronic diseases. The goal of the present study was to provide an overview of their current status in Iran. Methods: A comprehensive search of…

Author(s): Farhang Rezaei, PharmD, Nassim Anjidani, PharmD

biosimilars, Biotechnological therapeutics, follow-on biologics, Iran

DOI: 10.5639/gabij.2021.1002.010

Author byline as per print journal: Marta Zuccarelli1, PharmD; Benjamin Micallef1, PharmD; Mark Cilia1, PharmD; Anthony Serracino-Inglott1,2, PharmD; John-Joseph Borg1,3, PhD Introduction/Study Objectives: The development of biosimilars is challenging due to the complexity of the active substances as well as the strict regulatory requirements to show similarity with a reference medicinal product. This review aims…

biosimilars, clinical development programmes, EMA, EPARs, regulatory, safety

DOI: 10.5639/gabij.2021.1002.009

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Steven Simoens4, MSc, PhD; Amanj Kurdi1,5, BSc, PhD; Gisbert Selke6; John Yfantopoulos7, PhD; Andrew Hill8, PhD; Jolanta Gulbinovič9, MD, PhD; Antony P Martin10,11, MA, PhD1; Angela Timoney1,12, BPharm, PhD; Dzintars Gotham13, MBBS; Janet Wale14, PhD; Tomasz Bochenek15, PhD; Iva Selke Krulichova16, MSc, PhD; Eleonora Allocati17,…

cancer, cross-national, Europe, generics, health policies, pricing

DOI: 10.5639/gabij.2021.1002.008

Author byline as per print journal: Mansour Somaily1, MD; Hana Alahmari1, MD; Wejdan Abbag2; Shahenda Yousif4, MD; Nawar Tayfour4, MD; Nouf Almushayt2; Saleh Alhusayni3, MD; Saeed Almajadiah4, MD Background: A biosimilar version of infliximab (CT-P13) was recently approved for use in Saudi Arabia. Clinical data support its use in the treatment of rheumatic disease, however,…

Ankylosing spondylitis, Bechet's disease, CT-P13, infliximab, rheumatoid arthritis

DOI: 10.5639/gabij.2021.1002.007

Author byline as per print journal: Kelly Canham1, BSc Hons; Claire Newcomb2, MSc Introduction/Study Objectives: Etanercept is a tumour necrosis factor inhibitor indicated for the treatment of several inflammatory disorders. Patients with these diseases may experience manual dexterity challenges. Autoinjectors may improve dose accuracy, treatment adherence and quality of life; and reduce injection-site reactions. Studies…

autoinjector, biosimilar, etanercept, usability, YLB113

DOI: 10.5639/gabij.2021.1002.006

Editor's Letter

Published on 20 May 2021

What to look forward to in GaBI Journal, 2021, Issue 2

The current pandemic has greatly amplified the already existing disparities in access to health care. Many countries are facing a lack of access to or funding to pay for the vaccines, medications, protective equipment, and supplies; even ­oxygen to deal with either COVID-19, wars, famine, and other life-threatening conditions. Patients, families and governments are all…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2021.1002.005

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Teh Kee Siang, BSc (Pharm)(Hon); Associate Professor Chan Lai Wah, BSc (Pharm)(Hon), PhD Continuous manufacturing (CM) is the integration of a series of unit operations, processing materials continually to produce the final pharmaceutical product. In recent years, CM of pharmaceuticals…

batch manufacturing, challenges, continuous manufacturing, harmonization, opportunity, regulatory

DOI: 10.5639/gabij.2021.1001.004