Review Article

An overview of the current status of follow-on biologicals in Iran

Published in: Volume 10 / Year 2021 / Issue 2
Author(s): ,
Page: 100-6

Background The advent of follow-on biologicals in Iran and biosimilars worldwide have provided various treatment options for several severe and chronic diseases. The goal of the present study was to… Read More »

The EU regulatory network and emerging trends – a review of quality, safety and clinical development programmes

Published in: Volume 10 / Year 2021 / Issue 2
Page: 83-99

Author byline as per print journal: Marta Zuccarelli1, PharmD; Benjamin Micallef1, PharmD; Mark Cilia1, PharmD; Anthony Serracino-Inglott1,2, PharmD; Professor John-Joseph Borg1,3, PhD Introduction/Study Objectives: The development of biosimilars is challenging… Read More »

Continuous manufacturing versus batch manufacturing: benefits, opportunities and challenges for manufacturers and regulators

Published in: Volume 10 / Year 2021 / Issue 1
Page: 44-56

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Teh Kee Siang, BSc (Pharm)(Hon); Associate Professor Chan Lai Wah, BSc (Pharm)(Hon), PhD Continuous manufacturing… Read More »

Pharmaceutical Data Integrity: issues, challenges and proposed solutions for manufacturers and inspectors

Published in: Volume 9 / Year 2020 / Issue 4
Author(s): , , ,
Page: 171-82

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock1, BSc (Pharm), MSc; Vernon Tay1, BSc (Pharm) (Hons); Vimal Sachdeva2, MSc; Associate Professor Chan Lai Wah1, BSc (Pharm)… Read More »

Current trends for biosimilars in the Latin American market

Published in: Volume 9 / Year 2020 / Issue 2
Page: 64-74

Author byline as per print journal: Esteban Ortiz-Prado1,2, MD, MSc, MPH, PhD; Jorge Ponce-Zea3, MSc; Jorge E Vasconez1, MD; Diana Castillo,1, MD; Diana C Checa-Jaramillo1, MD; Nathalia Rodrí­guez-Burneo1, MD; Felipe… Read More »

Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals

Published in: Volume 9 / Year 2020 / Issue 2
Author(s): , ,
Page: 52-63

Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Associate Professor Sia Ming Kian, BSc (Pharm) (Hons); Chan Lai Wah, BSc (Pharm) (Hons), PhD… Read More »

An ever-evolving landscape: an update on the rapidly changing regulation and reimbursement of biosimilars in Canada

Published in: Volume 8 / Year 2019 / Issue 3
Author(s): , , , ,
Page: 107-18

Author byline as per print journal: Eric CK Siu1,4, MSc, PhD; Anne Tomalin2,4, BA, BSc; Kevin West3,4, BA; Sandra Anderson4, BA, MBA; George Wyatt1,4, BSc, MBA Abstract: Since the introduction… Read More »

Are there biosimilar orphan drugs for Gaucher disease? An overview in Mexico

Published in: Volume 8 / Year 2019 / Issue 2
Author(s): , , , , , , , , , ,
Page: 71-5

Author byline as per print journal: G Castañeda-Hernández, PhD; L Carbajal-Rodríguez, MD; M Cerón-Rodríguez, MD; Professor LC Correa-González, MD; A Esquivel-Aguilar, PhD; SJ Franco-Ornelas, MD; JE García Ortiz, PhD; CM… Read More »

The need for distinct nomenclature for originator and biosimilar products

Published in: Volume 7 / Year 2018 / Issue 4
Author(s): , , ,
Page: 152-7

Author byline as per print journal: Michael Sarshad, BSc, MBA; Rosanne Campbell, BComm, PGdip, MSc; Peter J Pitts, BA; Jacqueline anderpuye- Orgle, MSc, PhD Abstract: As the number of biosimilar… Read More »

Protein heterogeneity and the immunogenicity of biotherapeutics

Published in: Volume 7 / Year 2018 / Issue 2
Author(s):
Page: 63-9

Abstract: High resolution analytical techniques reveal structural micro-heterogeneity within endogenous proteins, however, they are ‘seen’ as ‘self’ molecules by the immune system and immunological tolerance is established. In contrast the… Read More »

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