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Published on 19 August 2022

Front-loading biosimilar development with analytical characterization

Abstract: An online roundtable discussion entitled ‘Front-loading biosimilar development with analytical characterization’ was hosted by BioPharmaSpec. The panellists discussed different regulatory approaches to the clinical trials needed for approval and how this can affect structural and functional characterization; the best way to ‘front-load’ characterization Submitted: 18 June 2022 Revised: 19 July 2022; Accepted: 20 July…

Author(s): Richard L Easton, BSC (Hons), DIC, PhD

analytics, biosimilars, functional testing, orthogonality, structural characterization

DOI: 10.5639/gabij.2022.1102.013

Contents Editor’s Letter First 2022 GaBI Journal issue highlights Letter to Editor No need for systematic switch studies to demonstrate interchangeability of biosimilars Review Article Biotherapeutic products in the European Pharmacopoeia: have all challenges been tackled? Challenges in the manufacture, storage, distribution and regulation of traditional and novel vaccines Long-acting insulin analogues. Drug selection by…

Editor's Letter

Published on 26 April 2022

First 2022 GaBI Journal issue highlights

The first GaBI Journal issue of 2022 comes at a time of both hope and despair. While the COVID-19 pandemic continues to cause significant global morbidity and mortality; especially in resource-poor countries, both the pace and direction of changes are beginning to produce some encouraging signs. Positive trends are in part the result of the…

Author(s): Professor Philip D Walson, MD

DOI: 10.5639/gabij.2022.1101.001

Contents Editor’s Letter First 2021 GaBI Journal issue highlights Original Research Biosimilars – status in July 2020 in 16 countries An assessment of trends in the Iranian pharmaceutical market following domestic production of selected medications (2007‒2017) and new considerations for health policymakers Review Article Continuous manufacturing versus batch manufacturing: benefits, opportunities and challenges for manufacturers…

Author byline as per print journal: Andriy Krendyukov, MD, PhD; Marta Bakowska, BA (Hon), MPH; Dirk Schiller, PhD; Sanjay Singhvi, BSc (Hon), MBBS, MBA Introduction: Healthcare providers often lack familiarity with the concepts surrounding the biosimilars industry and the evidence required to support biosimilar development. This paper assesses current understanding, knowledge and perception of biosimilars…

biosimilar, education, oncology, regulatory

DOI: 10.5639/gabij.2024.1301.005

Contents Editor’s Letter What to look forward to in GaBI Journal, 2021, Issue 2 Original Research Summative usability evaluation of the YLB113 etanercept biosimilar autoinjector via simulation Biosimilars in Saudi Arabia: a single-centre, open-label case series examining infliximab switching Variation in the prices of oncology medicines across Europe and the implications for the future Review…

Contents Editor’s Letter Latest features in GaBI Journal, 2021, Issue 3 Original Research Pharmacokinetics and bioequivalence of generic etoricoxib in healthy volunteers Reasons for patients’ generic drug switching at the pharmacy counter: a pilot study Review Article A critical review of substitution policy for biosimilars in Canada Microbiological, scientific and regulatory perspectives of hand sanitizers…

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Doxorubicin Accord 2 mg/mL concentrate in original glass vials after first opening and after transfer to polypropylene (PP) syringes as well as diluted Doxorubicin Accord solutions (0.05 mg/mL, 1.6 mg/mL) in 0.9%…

concentrated solution, diluted infusion solution, doxorubicin, physicochemical stability

DOI: 10.5639/gabij.2024.1302.011

Abstract: The physicochemical stability of Azacitidine Accord, a pyrimidine analogue antineoplastic agent, was assessed after reconstitution with cold water for injection (WFI) and storage in original glass vials and polypropylene (PP) syringes at different temperatures. At 2°C–8°C, stability was observed for 3 days in both containers. At -20°C, stability was maintained for 60 days regardless…

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

azacitidine, physicochemical stability, suspension for injection

DOI: 10.5639/gabij.2024.1302.023

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of Oxaliplatin Accord 5 mg/mL in punctured original vials and after dilution with 5% glucose solution in polyethylene (PE) bottles and polyolefine (PO) bags at different concentrations and different storage conditions. Methods: Test…

concentrated solution, diluted infusion solution, oxaliplatin, physicochemical stability

DOI: 10.5639/gabij.2024.1302.022

Author byline as per print journal: Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD Study objectives: To determine the physicochemical stability of undiluted Cisplatin Accord 1 mg/mL in punctured original vials and polypropylene (PP) syringes as well as after dilution with 0.9% sodium chloride solution in polyethylene (PE) bottles at two different concentrations (0.01…

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

DOI: 10.5639/gabij.2024.1302.021

Contents Editor’s Letter Fourth and final issue of GaBI Journal’s 10th volume Original Research Extended stability of the trastuzumab biosimilar ABP 980 (KANJINTIâ„¢) in polyolefin bags and elastomeric devices Review Article The European framework for intellectual property rights for biological medicines Biotechnological therapies and biosimilars for COVID-19: scarcities, poor regulation, and pharmaceutical black market: a…