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

Submitted: 28 November 2016; Revised: 29 November 2016; Accepted: 30 November 2016; Published online first: 5 December 2016 In the journal Blood, Jones et al. [1] discuss strategies used by brand pharmaceutical companies, often in combination, to delay market entry of affordable generic drugs in the US and other countries. They highlight how these strategies…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0504.051

Editor's Letter

Published on 03 July 2013

What to look forward to in GaBI Journal, 2013, Issue 2

The first of two Letters to the Editor is from Ms Gaspani and Ms Milani expressing their concerns about the lack of clear regulatory guidelines for approval of liposomal generic formulations. Liposomal products are only one and perhaps some of the best-characterized example of non-biological complex drugs (NBCDs). NBCDs while not having a biological source…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2013.0202.028

Submitted: 29 February 2016; Revised: 15 March 2016; Accepted: 16 March 2016; Published online first: 29 March 2016 Use of brand name drugs over generic equivalents after expiration of exclusivity still prevails. Ameet Sarpatwari and Aaron Kesselheim argue the case for reforming drug naming by allowing generic products to share the brand names of their…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2016.0501.012

Submitted: 29 December 2017; Revised: 5 January 2018; Accepted: 12 January 2018; Published online first: 19 January 2018 A recent comparison of generic drug markets [1] explores the history of generics substitution and bioequivalence policies in the US, in order to understand the barriers to implementing reform of generic drug policies. The history of generics…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2018.0701.009

Abstract: This article describes the European Pharmacopoeia (Ph. Eur.) exploratory study on infliximab as a test case for developing public standards for monoclonal antibodies. The design and outcome of the feasibility study, importance of interaction with stakeholders and the challenges and lessons learned are discussed. Emphasis is put on the approach used to set the…

Author(s): Mihaela Buda, PhD

flexibility, infliximab, monographs, pharmacopoeia, public standards, reference preparations

DOI: 10.5639/gabij.2022.1103.017

Abstract: Low-cost generic drug programs (LCGPs) provide affordable generics in the US. However, LCGPs have implications for managed care organizations and researchers relying on claims data. Submitted: 7 March 2016; Revised: 5 April 2016; Accepted: 5 April 2016; Published online first: 18 April 2016 Low-cost generic drug programs (LCGPs) in the US increase the affordability…

Author(s): Joshua D Brown, PharmD, MS

generic medicines, low-cost generic drug programs, quality assessment, United States healthcare system

DOI: 10.5639/gabij.2016.0501.003

Editor's Letter

Published on 05 September 2014

Latest features in GaBI Journal, 2014, Issue 3

This issue of the GaBI Journal begins with editorial comments from our Deputy Editor-in-Chief Dr Robin Thorpe concerning the Review Article by Azevedo et al. covering biosimilar regulations and their implementation in some Latin American countries. Three Original Research papers describe real life clinical examples relating to the use and evaluation of follow-on products respectively;…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2014.0303.026

Abstract: Current regulations do not require a given biosimilar to remain similar to its reference biological over time. However, two products that were initially deemed biosimilar or interchangeable could each undergo unique patterns of drift and evolution in their manufacturing processes (divergence), ultimately resulting in two products that would be no longer biosimilar. In cases…

Author(s): Pablo Matar, PhD

divergence, drift, evolution, interchangeability, pharmacovigilance, variability

DOI: 10.5639/gabij.2022.1101.006

Submitted: 29 January 2019; Revised: 4 February 2019; Accepted: 5 February 2019; Published online first: 14 February 2019 Generic prescription drug prices have been escalating rapidly in the US. In 2014 alone, generic drug prices increased by 38% on average. Public outcry has led to a flurry of recent legislative proposals, and two federal bills…

Author(s): GaBI Journal Editor

DOI: 10.5639/gabij.2019.0802.010

Abstract: The US Food and Drug Administration (FDA) outlines its approach to biosimilarity and interchangeability at the 2016 Generic Pharmaceutical Association Biosimilars Council Conference. Topics covered include the FDA definition of biosimilarity, its step-wise approach to the approval process and factors/issues that should be considered when providing scientific justification for extrapolation. Submitted: 22 September 2016;…

Author(s): GaBI Journal Editor

biologicals, biosimilar, biosimilarity, interchangeability, regulation

DOI: 10.5639/gabij.2016.0503.035

Abstract: Monoclonal antibodies and cell therapies play an increasingly significant role in anticancer therapy, but small molecules remain an essential part of combination chemotherapy. Despite the publication of many studies on the extended stability of small molecule preparations, not all licensed medicinal products and stability-determining factors are covered. Submitted: 26 April 2024; Revised: 9 May…

Author(s): Irene Krämer, PhD, Judith Thiesen, PhD

anticancer drugs, cytotoxic, in-use stability, parenteral administration

DOI: 10.5639/gabij.2024.1302.010