Articles

Special Report

Published on 11 September 2024

Physicochemical stability of Topotecan Accord after dilution with 0.9% sodium chloride or 5% glucose solution in polyolefine and non-PVC bags

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Topotecan Accord 1 mg/mL concentrate diluted with...

diluted infusion solution, HPLC, physicochemical stability, topotecan

DOI: 10.5639/gabij.2024.1302.017

319 views

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Special Report

Published on 11 September 2024

Physicochemical stability of Vinorelbine Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Vinorelbine Accord in original vials after first...

HPLC, physicochemical stability, vinorelbine

DOI: 10.5639/gabij.2024.1302.019

394 views

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Editor's Letter

Published on 10 September 2024

What to look forward to in GaBI Journal, 2024, Issue 2

Issue 2 of Volume 13 of GaBI ­Journal starts with a Review Article by Paul et al., titled ‘Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income...

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2024.1302.007

422 views

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Perspective

Published on 14 August 2024

The challenge for drug shortage: lessons learned from the quality issues of Japanese generic drug companies

Author byline as per print journal: Takanao Hashimoto1, PhD; Akihiko Ozaki2, MD, PhD; Hiroaki Saito3, MD; Erika Yamashita4, Tetsuya Tanimoto5, MD; Mihajlo Jakovljevic6,7,8, MD, PhD Abstract: This paper examines the...

COVID-19 pandemic, drug shortages, generic drugs, good manufacturing practice, pharmaceutical policy

DOI: 10.5639/gabij.2024.1303.036

980 views

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Perspective

Published on 12 August 2024

US interchangeability designation: are we ready to cut the Gordian knot?

Author byline as per print journal: Joseph P Park1, PhD; Gillian R Woollett2, MA, DPhil Abstract: US Food and Drug Administration’s (FDA) current thinking on interchangeability has evolved since the...

Author(s): Gillian R Woollett, MA, DPhil, Joseph P Park, PhD

biosimilars, BPCIA, interchangeability, market exclusivity, quality, switching

DOI: 10.5639/gabij.2024.1303.035

1.951 views

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Editor's Letter

Published on 11 July 2024

First 2024 GaBI Journal issue highlights

It was with great pleasure that I assumed the role of Editor-in-Chief (EiC) of GaBI Journal in January of this year. Taking over the helm from Professor Philip D Walson...

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2024.1301.001

991 views

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Special Report

Published on 11 July 2024

Extended stability data on small molecule anticancer medicinal products – anything new? any additional information necessary?

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...

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

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

DOI: 10.5639/gabij.2024.1302.010

4.318 views

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Perspective

Published on 11 July 2024

Misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health

Author byline as per print journal: Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF Abstract: The US biosimilar programme has been highly successful with 53 biosimilars approved...

biosimilarity, interchangeability, misinformation, regulation, uptake

DOI: 10.5639/gabij.2024.1302.009

2.623 views

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Review Article

Published on 26 June 2024

Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials

Author byline as per print journal: Shivani Mittra1, MPharm, PhD; Shylashree Baraskar1, MBBS; Elena Wolff -Holz2, MD; Sandeep N Athalye1, MBBS, MD Abstract: Drug development is among the highest producers...

biological, biosimilars, carbon footprint, clinical trials, ESG (Environmental Social Governance), sustainability

DOI: 10.5639/gabij.2024.1303.033

1.382 views

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Opinion

Published on 10 May 2024

Preserve the US interchangeable standard that has helped drive physician and patient confidence in biosimilars

Abstract: The US Food and Drug Administration (FDA) proposed eliminating the distinction between biosimilars and interchangeable biosimilars with the stated aim of aligning with European policy and enhance biosimilar uptake....

Author(s): Michael S Reilly, Esq

formulary, interchangeable biosimilar, market uptake, pharmacy benefit managers

DOI: 10.5639/gabij.2024.1301.006

2.235 views

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Review Article

Published on 07 May 2024

Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries

Author byline as per print journal: Pritha Paul1, PhD; Rahul Kapur2*, MBBS, PhD; Shivani Mittra3, MPharm, PhD; Nimish Shah4, JD, MBA; Gopal K Rao1, MSc; Matthew E Erick4, BS, RPh;...

affordability, biosimilars, low- and middle-income countries (LMICs), market access, non-communicable diseases, regulatory framework

DOI: 10.5639/gabij.2024.1302.008

5.530 views

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Perspective

Published on 19 April 2024

Comparative efficacy studies of biosimilars: data versus theoretical risks, beliefs, and comfort

Abstract: In principle, biosimilars could mitigate the problem of the rising cost of biological medicines. However, the current stringent and non-harmonized regulatory practices hinder competition and contribute to the high...

Author(s): Adjunct Professor Pekka Kurki, MD, PhD

biosimilars, competition, controlled efficacy studies, harmonization

DOI: 10.5639/gabij.2024.1301.004

2.044 views

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