Articles

Interview

Published on 07 November 2024

Transforming health care: CinnaGen’s leadership in follow-on biologicals/biosimilars development and market expansion

Abstract:CinnaGen, the largest biopharmaceutical company in the MENA region, is a leader in developing follow-on biologicals/biosimilars. Dr Haleh Hamedifar, Chairperson of CinnaGen, spoke to GaBI (Generics and Biosimilars Initiative) about...

Author(s): GaBI Journal Editor

biosimilars, clinical development, commercialization, MENA (Middle East and North Africa)

DOI: 10.5639/gabij.2024.1303.037

828 views

Read more →

Perspective

Published on 23 August 2024

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

Abstract:This paper examines the repercussions of recent quality and regulatory crises in Japan’s generic pharmaceutical sector, focusing on incidents involving Sawai Group Holdings (Sawai GHD) and other manufacturers. It provides...

Author(s): Takanao Hashimoto, PhD, Akihiko Ozaki, MD, PhD, Hiroaki Saito, MD, Erika Yamashita, Tetsuya Tanimoto, MD, Professor Mihajlo (Michael) Jakovljevic, MD, PhD, MAE

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

DOI: 10.5639/gabij.2024.1303.036

1.442 views

Read more →

Perspective

Published on 21 August 2024

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

Abstract:US Food and Drug Administration’s (FDA) current thinking on interchangeability has evolved since the legal designation was first created in 2010. Based on experience, FDA now acknowledges that clinical switching...

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

2.477 views

Read more →

Review Article

Published on 18 November 2024

A review of international initiatives on pharmaceutical regulatory reliance and recognition

Abstract:In light of recent global health challenges, the need for regulatory reliance – where one regulatory authority accepts the decisions of another – has gained significant interest and momentum. A...

Author(s): Vimal Sachdeva, MSc

authorization, best practice, harmonization, pharmaceuticals, recognition

DOI: 10.5639/gabij.2024.1303.034

1.587 views

Read more →

Review Article

Published on 30 July 2024

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

Abstract:Drug development is among the highest producers of greenhouse gas (GHG) emissions, with about 4.4%–4.6% of the worldwide GHG emissions coming from the thousands of clinical trials being carried out...

Author(s): Shivani Mittra, MPharm, PhD, Shylashree Baraskar, MBBS, Elena Wolff-Holz, MD, Sandeep N Athalye, MBBS, MD

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

DOI: 10.5639/gabij.2024.1303.033

1.688 views

Read more →

Editor's Letter

Published on 17 January 2025

Third and final issue of GaBI Journal’s 13th volume

This third issue of GaBI Journal is the last of the volume for this year and marks the end of the first year of me taking up the Editor-in-Chief position...

Author(s): Robin Thorpe, PhD, FRCPath

DOI: 10.5639/gabij.2024.1303.032

386 views

Read more →

Special Report

Published on 11 September 2024

Physicochemical stability of Fludarabine Accord in punctured original vials and after dilution with 0.9% sodium chloride solution

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To assess the physicochemical stability of fludarabine in punctured original vials and after...

concentrated solution, diluted infusion solution, fludarabine, HPLC, physicochemical stability

DOI: 10.5639/gabij.2024.1302.031

540 views

Read more →

Special Report

Published on 11 September 2024

Physicochemical stability of Pemetrexed Accord 25 mg/mL in punctured original vials and after dilution with 0.9% sodium chloride solution in non-PVC bottles

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Abstract: In this study, the physicochemical stability of Pemetrexed Accord 25 mg/mL concentrate and its...

concentrated solution, diluted infusion solution, HPLC, pemetrexed, physicochemical stability

DOI: 10.5639/gabij.2024.1302.030

537 views

Read more →

Special Report

Published on 11 September 2024

Physicochemical stability of Methotrexate Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution in non-PVC bags

Author byline as per print journal: Irene Krämer, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Methotrexate Accord 25 mg/mL concentrate in punctured original vials and...

concentrated solution, diluted infusion solution, methotrexate, physicochemical stability

DOI: 10.5639/gabij.2024.1302.029

712 views

Read more →

Special Report

Published on 11 September 2024

Physicochemical stability of Docetaxel Accord 20 mg/mL concentrate diluted with 0.9% sodium chloride or 5% glucose solution in 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 Docetaxel Accord infusion solutions 0.3 mg/mL and...

diluted infusion solution, docetaxel, HPLC, physicochemical stability

DOI: 10.5639/gabij.2024.1302.028

759 views

Read more →

Special Report

Published on 11 September 2024

Physicochemical stability of Cabazitaxel Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution in non-PVC bottles

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

cabazitaxel, concentrated solution, diluted infusion solution, HPLC, physicochemical stability

DOI: 10.5639/gabij.2024.1302.027

748 views

Read more →

Special Report

Published on 11 September 2024

Physicochemical stability of Gemcitabine Accord 100 mg/mL in punctured original vials and after dilution with 0.9% sodium chloride in polyolefine bags

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Gemcitabine Accord 100 mg/mL concentrate in original...

concentrated solution, diluted infusion solution, gemcitabine, physicochemical stability

DOI: 10.5639/gabij.2024.1302.026

593 views

Read more →