Meeting Report

Published on 14 September 2023

Medicare drug price negotiations: impact on healthcare development and patient access to medicines

Author byline as per print journal: Michael S Reilly, Esq; Thomas R Barker, Esq, JD; Charles M Clapton, Esq; Steven J Potts, PhD, MBA; Andrew Spiegel, Esq Introduction: In the US, a Medicare drug price negotiation provision has been introduced in the form of the 2022 Inflation Reduction Act (IRA). An online webinar on the…

DOI: 10.5639/gabij.2023.1203.015

Author byline as per print journal: Ka-Liong Tan1, DPhil; Ainoon Othman1; Irwan Mohd Subri2,3; Noor Fadzilah Zulkifli1; Mohd Mahyeddin Mohd Salleh3; Nazariyah Yahaya4; Khairun Nain Nor Aripin1; Shahirah Nadiah Shaharuddin5; Seri Azalina Mohd Ghazalli6; Muhammad Syazan Sulaiman6 Abstract: In recent years, there has been a rapid growth of the halal pharmaceutical industry, especially in the…

halal assurance, halal pharmaceuticals, oral dosage, supply chain

DOI: 10.5639/gabij.2023.1203.014

Author byline as per print journal: Ali M Alhomaidan, PhD; Mohammed Abdulaziz Alageel, MSc; Turki Abdulaziz Alrafie, MSc; Hassan Mohammed Alqarni, MSc; Ibraheem Yahya Khbrani, MSc; Dalal J Alkhamis, MSc; Mohammed F Alkhalifah, MSc; Abdualmajeed S bin Jumaiah, MSc; Mohammed A Dahhas, PhD Abstract: The Saudi Food and Drug Authority’s (SFDA) pharmaceutical products approval and…

Common Technical Documents, drug regulation, good manufacturing practice, Saudi FDA

DOI: 10.5639/gabij.2023.1203.013

Editor's Letter

Published on 10 January 2024

Latest features in GaBI Journal, 2023, Issue 3

The articles in this issue of the GaBI ­Journal highlight two important issues that must be considered when reading scientific publications. The first two articles illustrate the rapidly expanding influence of non-US, non-European economies on the global pharmaceutical industry. The second two articles illustrate the need to carefully evaluate the role of any potential author…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2023.1203.012

Abstract: Brazilian requirements for approval of biosimilars are aligned with a strict regulatory process and ensure the same high standards of quality, safety and efficacy as for originator biologicals. Submitted: 29 September 2022; Revised: 26 January 2023; Accepted: 27 January 2023; Published online first: 9 February 2023 In Brazil, a legal framework for approving follow-on…

Author(s): Sílvia Helena Cestari de Oliveira, MSc

biologicals, biosimilars, Brazil

DOI: 10.5639/gabij.2023.1202.011

Author byline as per print journal: Sandeep N Athalye1, MBBS, MD; Dev B Baruah1, MPharm; Shivani Mittra1, MPharm, PhD; Ankit Ranpura1, MD; Kuldeep Kumar1, PhD; Elena Wolff-Holz2, MD Abstract: Ethnic sensitivity assessments in the form of bridging pharmacokinetics (PK) studies are often needed for biosimilar monoclonal antibodies (mAbs) to meet regulatory requirements in regions like…

biosimilar development, ethnic sensitivity assessments, global access, monoclonal antibodies, multi-regional clinical trials, regulatory reforms

DOI: 10.5639/gabij.2023.1202.010

Author byline as per print journal: Jiayin Zheng1, PhD; Peijin Wang`2, MS; Yixin Wang3, PhD; Shein-Chung Chow2, PhD Abstract: For the biosimilarity assessment between a test product and a reference product, the US Food and Drug Administration (FDA) recommends a stepwise approach for obtaining totality-of-the-evidence in support of regulatory approval of the submission. The stepwise…

DOI: 10.5639/gabij.2023.1202.009

Author byline as per print journal: Michael S Reilly, Esq; Jane Barratt, PhD Introduction: The first biosimilar entered the Canadian market in 2009 and the first ophthalmic biosimilar was approved in 2022. In 2022, the Alliance for Safe Biologic Medicines (ASBM) and the International Federation on Ageing (IFA) asked prescribing ophthalmology physicians in Canada for…

biologicals, biosimilars, Canada, ophthalmology

DOI: 10.5639/gabij.2023.1202.008

Editor's Letter

Published on 14 September 2023

Extrapolation requires reading between the lines

The articles in this second issue of 2023 include an Original Research (Internet questionnaire) of the ‘opinions’ of Canadian ophthalmologists, a Review Article describing a statistical method to assess the ‘drift’ in the attributes of a reference, originator biological product, a Perspective (opinion) article questioning the value of ethnic sensitivity studies (ESS) in the evaluation of…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2023.1202.007

Author byline as per print journal: Michael S Reilly, Esq; Gail Attara; Ralph D McKibbin, MD, FACP, FACG, AGAF; Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP Introduction: Biosimilars are now key players in the global drugs market offering potentially more affordable treatment options with similar safety and efficacy. However, there are concerns about non-medical…

biologicals, biosimilars, forced-switching, interchangeable biosimilar, non-medical switching

DOI: 10.5639/gabij.2023.1201.006

Author byline as per print journal: Sandeep N Athalye, MBBS, MD; Shivani Mittra, MPharm, PhD; Ankitkumar M Ranpura, MD Abstract: The sky-rocketing cost of developing biosimilars is becoming a shared deterrent for biosimilar developers. The regulatory requirements for biosimilars must see a natural evolution and a paradigm shift towards removing inefficiencies in clinical designs to…

biosimilars, immunogenicity, interchangeability, switch studies

DOI: 10.5639/gabij.2023.1201.005

Author byline as per print journal: Chuei Wuei Leong1, PhD; Elton Sagim1, BBiomedSc, Kar Ming Yee1, BPharm; Muhammad Shalhadi Saharuddin1, BSc; Sharifah Radziah Syed Abd Rahim1, MSc; Khairil Sabri1, BSc; Mohd Zulhairi Jamaluddin1, BSc; Shahnun Ahmad1, MBBS; Atiqah Amran1, BSc; Rabab F Tayyem2, PhD Introduction/Study Objectives: The present study aimed to evaluate the comparative bioavailability…

bioequivalence, new branded generics, sitagliptin hydrochloride, sitagliptin phosphate

DOI: 10.5639/gabij.2023.1201.004