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Comment on ‘Misinformation about interchangeable biosimilars’
Author byline as per print journal: Hillel P Cohen, PhD; Caridad Pontes, MD, PhD; Fernando de Mora, MBA, PhD Abstract: The...
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 ...
Letter to the Editor: Comment on the article by Reilly MS and McKibbin RD
Abstract: Reilly and McKibbin oppose the update of FDA interchangeability guidance that does not require clinical switch s...
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 a...
Transforming healthcare: 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 biologic...
Physicochemical stability of Etoposide Accord in punctured original vials and after dilution with 0.9% sodium chloride or 5% glucose solution
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
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
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
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
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
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: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
Physicochemical stability of Cytarabine Accord in punctured original vials and after dilution with 0.9% sodium chloride solution in polyolefine bags
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
Physicochemical stability of Cisplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride solution
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
Physicochemical stability of Carboplatin Accord in punctured original vials, syringes and after dilution with 0.9% sodium chloride or 5% glucose solution
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
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: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Study o...
Physicochemical stability of Bortezomib Accord 2.5 mg/mL and diluted 1 mg/mL intravenous injection solution in punctured original vials and polypropylene syringes
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Abstrac...
Physicochemical stability of Azacitidine Accord 25 mg/mL suspension for injection in original vials and polypropylene syringes after reconstitution with refrigerated water for injection
Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany Abstrac...
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...
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 Adminis...
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 biosimi...
Extended stability data on small molecule anticancer medicinal products – anything new? any additional information necessary?
Author byline as per print journal: Professor Irene Krämer, PhD; Judith Thiesen, PhD Abstract: Monoclonal antibodies and c...
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. Takin...
Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials
Author byline as per print journal: Sandeep N Athalye, MBBS, MD; Shylashree Baraskar; Shivani Mittra, MPharm, PhD; Elena W...
Preserve the US interchangeable standard that has helped drive physician and patient confidence in biosimilars
Abstract: The US FDA proposed eliminating the distinction between biosimilars and interchangeable biosimilars, aiming to a...
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 Mittra2, MPharm, PhD; Nimish Sha...
Comparative efficacy studies of biosimilars: data versus theoretical risks, beliefs, and comfort
Abstract: Ethnic sensitivity assessments in the form of bridging pharmacokinetics (PK) studies are often needed for biosim...
Budget impact analysis of a rituximab intravenous biosimilar in patients with follicular lymphoma and large B-cell non-Hodgkin lymphoma in Chile
Author byline as per print journal: Tomás Abbot1, MSc; Nicolás Armijo1, MSc; Robin Piron2, PhD; Manuel Espinoza1, 3, PhD I...
Current understanding, knowledge, and perception of biosimilars in a changing landscape of regulatory requirements
Author byline as per print journal: Andriy Krendyukov, MD, PhD; Marta Bakowska, BA (Hon), MPH; Dirk Schiller, PhD; Sanjay ...
Infliximab discontinuation in patients with originator retransition vs. biosimilar continuation
Submitted: 4 November 2023; Revised: 24 November 2023; Accepted: 27 November 2023; Published online first: 28 November 202...
Pharmacokinetic bioequivalence studies of a new Etoricoxib tablet formulation developed using proprietary MiST technology — risk assessment and mitigation using GastroPlus software
Author byline as per print journal: Dhananjay Panigrahi1, MPharm; Aditya Murthy2, MPharm, PhD; Shubham Jamdade2, MPharm; M...
Switches between biosimilars and their reference products
Biologics are the fastest-growing class of medications in the United States and account for a substantial and growing port...
Latest features in GaBI Journal, 2023, Issue 3
The articles in this issue of the GaBI Journal highlight two important issues that must be considered when reading scienti...
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