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Canadian prescribers’ attitudes and perceptions about ophthalmic biosimilars
Author byline as per print journal: Michael S Reilly, Esq; Jane Barratt, PhD Introduction: The first biosimilar entered th...
Statistical tests for detecting reference product change in biosimilar studies
Author byline as per print journal: Jiayin Zheng1, PhD; Peijin Wang2, MS; Yixin Wang3, PhD; Shein-Chung Chow2, PhD Abstrac...
Lagging acceptance of generic and biosimilar drug products; the rest of the story
The articles in this issue of the GaBI Journal reminded me of The Rest of the Story radio programme originally hosted by M...
Non-medical switching of biologicals/biosimilars Canada, Europe and the US: a webinar report
Author byline as per print journal: Michael S Reilly, Esq; Gail Attara; Ralph D McKibbin, MD, FACP, FACG, AGAF; Professor ...
Biosimilars approved in Brazil 2022
Author byline as per print journal: Sílvia Helena Cestari de Oliveira, MSc Abstract: In Brazil, a legal framework for appr...
Pharmacokinetics and relative bioavailability of sitagliptin hydrochloride and sitagliptin phosphate tablets formulations: a randomized, open-label, crossover study in healthy male volunteers
Author byline as per print journal: Chuei Wuei Leong, PhD; Elton Sagim, BBiomedSc, Kar Ming Yee, BPharm; Muhammad Shalhadi...
Biosimilars drug development: time for a paradigm shift?
Author byline as per print journal: Sandeep N Athalye, MS; Shivani Mittra, MPharm, PhD; Ankitkumar M Ranpura, MD Abstract:...
Response to the Opinion entitled ‘Biosimilars drug development: time for a paradigm shift?’
Abstract: The Opinion published in this issue of GaBI Journal titled 'Biosimilars drug development: time for a paradi...
The importance of trust
It seems as if the entire world is dealing with a lack of trust, even in many things that have enriched and sustained huma...
Social trust and regional variation in the adoption of biosimilars in Italy and Germany
Author byline as per print journal: James C. Robinson, PhD, MPH Introduction/Study Objectives: Adoption of biosimilars has...
Pharmacokinetic bioequivalence of sitagliptin phosphate tablet formulations: a randomized, open-label, crossover study in healthy volunteers
Author byline as per print journal: Chuei Wuei Leong*,1, PhD; Elton Sagim1, BBiomedSc; Kar Ming Yee1, BPharm; Muhammad Sha...
Development of Ph. Eur. standards for therapeutic monoclonal antibodies: infliximab case study
Keywords: Monoclonal antibodies, pharmacopoeia, infliximab, public standards, flexibility Author byline as per print journ...
Key factors for successful uptake of biosimilars: Europe and the US
Introduction: Biosimilars were first introduced in Europe in 2006 and then in the US in 2015. An online webinar on the suc...
What to look forward to in GaBI Journal, 2022, Issue 2
The rate of successful development, regulatory approval and marketing of both new and follow-on biological treatments has ...
US prescribers’ attitudes and perceptions about biosimilars
Author byline as per print journal: Ralph McKibbin, MD; Michael S Reilly, Esq Introduction: In the United States (US), a l...
Social trust, economic incentives, and regional variation in the adoption of biosimilars in italy and germany
Author byline as per print journal: James C. Robinson, PhD, MPH Introduction/Study Objectives: Adoption of biosimilars has...
Key factors for successful uptake of biosimilars: Europe and US
Author byline as per print journal: Michael S Reilly, Esq; Professor Philip J Schneider, MS, FASHP, FASPEN, FFIP Introduct...
Front-loading biosimilar development with analytical characterization
Abstract: An online roundtable discussion entitled 'Front-loading biosimilar development with analytical characteriza...
On statistical evaluation for interchangeability of biosimilar products
Author byline as per print journal: Yuqi Li, BS Pharm; Professor Shein-Chung Chow, PhD Abstract: A biosimilar product is a...
Substitution and interchangeability: time for a conversation?
Author byline as per print journal: Chad Rieger, MBA; Lisa Hall, PhD; David Lim, DPH Abstract: Bandiera et al. (2002) iden...
A case study of AstraZeneca’s omeprazole/esomeprazole chiral switch strategy
Abstract: Objective: To describe the chiral switch, an evergreening strategy used by AstraZeneca to position enantiopure e...
Structural characterization methods for biosimilars: fit-for-purpose, qualified or validated
Abstract: Detailed and accurate structural characterization of biopharmaceuticals is of paramount importance for product d...
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 ca...
Biosimilarity is not transitivity: implication for interchangeability, naming and pharmacovigilance
Abstract: Current regulations do not require a given biosimilar to remain similar to its reference biological over time. H...
Long-acting insulin analogues. Drug selection by means of the System of Objectified Judgement Analysis (SOJA)
Abstract: Objectives: The increasing number of long-acting insulin analogues makes it difficult for general practitioners ...
Sourcing innovator products in the age of biosimilar research
Sourcing innovator products in the age of biosimilar research Published in: Volu...
Manufacture and regulation of cell, tissue and gene therapy products: global perspectives, challenges and next steps
Abstract: Cell, tissue and gene therapy products (CTGTPs) are therapeutic products intended for use in humans for prophyla...
Challenges in the manufacture, storage, distribution and regulation of traditional and novel vaccines
Abstract: Since the onset of the COVID-19 pandemic, there has been a significant surge in interest of COVID-19 vaccines in...
Biotherapeutic products in the european pharmacopoeia: have all challenges been tackled?
Abstract: The monographs and associated physical reference standards of the European Pharmacopoeia (Ph. Eur.) are legally ...
No need for systematic switch studies to demonstrate interchangeability of biosimilars
Abstract: Biosimilars have been used for 15 years in the European Union (EU). They are able to trigger price competition a...
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