Forthcoming Issue

Editor’s introduction to the initial issue of the 14th volume of GaBI Journal

Robin Thorpe, PhD, FRCPath, UK

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

Robin Thorpe, PhD, FRCPath, UK

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

Robin Thorpe, PhD, FRCPath, UK

First 2024 GaBI Journal issue highlights

Robin Thorpe, PhD, FRCPath, UK

Rising costs of biologicals: effective cost-containment does not please all stakeholders

Adjunct Professor Pekka Kurki, MD, PhD, Finland

Comment on the article by Reilly MS and McKibbin RD

Adjunct Professor Pekka Kurki, MD, PhD, Finland

Comment on ‘Misinformation about interchangeable biosimilars’

Hillel P Cohen, PhD; Caridad Pontes, MD, PhD; Fernando de Mora, MBA, PhD

Therapeutic equivalence of a formulation of purified micronized flavonoid fraction of diosmin/hesperidin 450 mg/50 mg in healthy adults: an open-label, randomized, single-dose, crossover study 

Katherine Bouyer Sáez; Francisco Fuentes Poblete

An analysis of policy impacts on the price developments of biological medicines after patent expiration

Peter Schneider¹, MA; Alexander Guggenberger², BSc, MSc; Siegfried Eisenberg³, BSc, MSc, PhD; Lukas Rainer⁴, BSc, MSc 

Budget impact analysis of a rituximab intravenous biosimilar in patients with follicular lymphoma and large B-cell non-Hodgkin lymphoma in Chile

Tomás Abbot¹, MSc; Nicolás Armijo¹, MSc; Robin Piron², PhD; Manuel Espinoza^{1, 3}, PhD, Chile

Pharmacokinetic bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology — risk assessment and mitigation using GastroPlus software

Dhananjay Panigrahi¹, MPharm; Aditya Murthy², MPharm, PhD; Shubham Jamdade², MPharm; Manoj Gundeti², MPharm; Nagarjun Rangaraj¹, MPharm, PhD, MPharm; Anup Avijit Choudhury¹, MPharm; Tausif Ahmed², MPharm, PhD; Venkat Ramana Naidu¹, MPharm, PhD, India

A review of international initiatives on pharmaceutical regulatory reliance and recognition

Vimal Sachdeva, MSc, Switzerland

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

Sandeep N Athalye, MBBS, MD; Shylashree Baraskar, Shivani Mittra, MPharm, PhD; Elena Wolff-Holz, MD; India/Germany

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

Pritha Paul¹, PhD; Rahul Kapur^2,*, MBBS, PhD; Shivani Mittra², MPharm, PhD; Nimish Shah³, JD, MBA; Gopal K Rao¹, MSc; Matthew E Erick⁴, BS, RPh; Susheel Umesh1, BPharm, MBA; Sandeep N Athalye², MBBS, MD, India

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

Joseph P Park, PhD; Gillian R Woollett, MA, DPhil, South Korea

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

Takanao Hashimoto1, PhD; Akihiko Ozaki2, MD, PhD; Hiroaki Saito3, MD; Erika Yamashita4; Tetsuya Tanimoto5, MD; Mihajlo Jakovljevic6,7,8, MD, PhD, Japan

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

Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF, USA

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

Adjunct Professor Pekka Kurki, MD, PhD / Finland

Current understanding, knowledge, and perception of biosimilars in a changing landscape of regulatory requirements

Andriy Krendyukov, MD, PhD; Marta Bakowska, BA (Hon), MPH; Dirk Schiller, PhD; Sanjay Singhvi, BSc (Hon), MBBS, MBA, Germany/UK

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

Michael S Reilly, Esq, USA

Current trends in biosimilar uptake and special focus on automatic substitution – a symposium report

Professor Alan Lyles, BSPharm, MPH, ScD, PhD (h.c.); Heinonen E, MD, PhD; Tolonen HM, MSc (Pharm), PhD; Linden K, MSc (Pharm), MSc (Econ), PhD; Sihvo S, PhD; Sarnola K, MSc (Pharm), MSc (Econ), PhD; Airaksinen M, MSc (Pharm), PhD

Biosimilar Red Tape Elimination Act (S.2305): weakening FDA regulatory standards for biosimilars, undermining physician confidence and jeopardizing patient health

Michael S Reilly, Esq; Ralph D McKibbin, MD, FACP, FACG, AGAF, USA

Follow-on biologicals/biosimilars approved in Brazil: September 2025 update

Sílvia Helena Cestari de Oliveira, MSc; German Enrique Wassermann, PhD

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

Professor Irene Krämer, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Azacitidine Accord 25 mg/mL suspension for injection in original vials and polypropylene syringes after reconstitution with refrigerated water for injection

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Bortezomib Accord 2.5 mg/mL and diluted 1 mg/mL intravenous injection solution in punctured original vials and polypropylene syringes

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

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

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

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

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

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

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

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

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Docetaxel Accord 20 mg/mL concentrate diluted with 0.9% sodium chloride or 5% glucose solution in non-PVC bags

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Doxorubicin Accord 2 mg/mL in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyethylene bottles

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Epirubicin Accord 2 mg/mL in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyolefine bags

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

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

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

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

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Fluorouracil Accord in three different concentrations in portable elastomeric infusion pumps

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

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

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Idarubicin Accord in punctured original vials, syringes and after dilution with water for injection

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Irinotecan Accord in punctured original vials and polypropylene syringes and after dilution with 0.9% sodium chloride or 5% glucose solution in polyolefine bags

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

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

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Mitoxantrone Accord after dilution with 0.9% sodium chloride solution in polyolefine bags

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Physicochemical stability of Oxaliplatin Accord 5 mg/mL in punctured original vials and after dilution with 5% glucose solution in polyethylene bottles and polyolefine bags

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

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

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

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

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

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

Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Turkey’s biotech manufacturing ambitions: Yerlika Biopharma’s strategic role

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

Biosimilar trial failed? Investors get their money back: a new insurance model redefines clinical trial financing

Tomas J Philipson¹, PhD; Dhruva Gupta², MD; Jacob Shia¹, MBA; Rahul Gupta¹, MD, MPH, MBA, FACP

Regulatory pathway for approval of ‘biosimilars’ in Iran 

Jalal Naeli, MD, Iran