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 / USA/Spain

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 / Chile

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

Peter Schneider, MA; Alexander Guggenberger, BSc, MSc; Siegfried Eisenberg, BSc, MSc, PhD; Lukas Rainer, BSc, MSc / Austria

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

Tomás Abbot, MSc; Nicolás Armijo, MSc; Robin Piron, PhD; Manuel Espinoza, PhD / Chile

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

Dhananjay Panigrahi, MPharm; Aditya Murthy, MPharm, PhD; Shubham Jamdade, MPharm; Manoj Gundeti, MPharm; Nagarjun Rangaraj, MPharm, PhD, MPharm; Anup Avijit Choudhury, MPharm; Tausif Ahmed, MPharm, PhD; Venkat Ramana Naidu, 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 Paul, PhD; Rahul Kapur, MBBS, PhD; Shivani Mittra, MPharm, PhD; Nimish Shah, JD, MBA; Gopal K Rao, MSc; Matthew E Erick, BS, RPh; Susheel Umesh, BPharm, MBA; Sandeep N Athalye, MBBS, MD / India/USA

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

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

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

Takanao Hashimoto, PhD; Akihiko Ozaki, MD, PhD; Hiroaki Saito, MD; Erika Yamashita; Tetsuya Tanimoto, MD; Mihajlo Jakovljevic, MD, PhD / Japan/Serbia

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 / Finland/USA

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 / Brazil

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 Philipson, PhD; Dhruva Gupta, MD; Jacob Shia, MBA; Rahul Gupta, MD, MPH, MBA, FACP / USA

Regulatory pathway for approval of ‘biosimilars’ in Iran 

Jalal Naeli, MD / Iran