Review Article
Global challenges in the manufacture, regulation and international harmonization of GMP and quality standards for biopharmaceuticals
Author(s): Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc, Associate Professor Chan Lai Wah, BSc (Pharm) (Hon), PhD, Sia Ming Kian, BSc (Pharm) (Hons)
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
Author(s): Anne Tomalin, BA, BSc, Eric CK Siu, MSc, PhD, George Wyatt, BSc, MBA, Kevin West, BA, Sandra Anderson, BA, MBA
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
Author(s): A Esquivel-Aguilar, PhD, CM Hernández-Guadarrama, MD, E Terreros-Muñoz, MD, G Castañeda-Hernández, JE García Ortiz, PhD, JI Navarrete-Martínez, MD, L Carbajal-Rodríguez, MD, M Cerón-Rodríguez, MD, Professor LC Correa-González, MD, SJ Franco-Ornelas, MD, Y Santillán-Hernández
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
Author(s): 1 Michael Sarshad, BSc, MBA, 2 Rosanne Campbell, BComm, PGdip, MSc, 3 Peter J Pitts, BA, Jacqueline Vanderpuye-Orgle, MSc, PhD
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
Author(s): Professor Roy Jefferis, PhD, DSc, MRCP, FRCPath
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 »
The impact of religion on human embryonic stem cell regulations: comparison between the UK, Germany and the US
Author(s): Ali M Alhomaidan, PhD, Hajaj M Alhomaidan
Page: 22-5
Author byline as per print journal: Hajaj M Alhomaidan; Ali M Alhomaidan, PhD Abstract: This paper describes the differences in human embryonic stem cell regulations in several Christian countries across… Read More »
Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence
Author(s): 1 Gary L O’Brien, BPharm, MPharm, 2 Donal Carroll, BSc (Hon) Pharmacy, 3 Mark Mulcahy, BComm, MSc, PhD, 4 Valerie Walshe, BA, MA, PhD, Professor Garry Courtney, MB, FRCPI, Professor Stephen Byrne, BSc (Hon) Pharmacy, PhD
Page: 14-21
Author byline as per print journal: Gary L O’Brien1, BPharm, MPharm; Donal Carroll2, BSc (Hon) Pharmacy; Mark Mulcahy3, BComm, MSc, PhD; Valerie Walshe4, BA, MA, PhD; Professor Garry Courtney2, MB, FRCPI;… Read More »
Major lessons learned from Zarxio’s US launch: the start of a biosimilar revolution
Introduction: Launched in 2015, Zarxio™ (filgrastim-sndz) was the first biosimilar to gain US Food and Drug Administration (FDA) approval. In contrast, the first biosimilar was launched in Europe in 2006.… Read More »
Biosimilars in Italy: what do real-world data reveal?
Author(s): Armando A Genazzani, DPhil, MD, Assistant Professor Gianluca Trifirò, MD, PhD, Ilaria Marcianò, MSc, Ylenia Ingrasciotta, MSc
Page: 114-9
Author byline as per print journal: Assistant Professor Gianluca Trifirò, MD, PhD; Ylenia Ingrasciotta, MSc; Ilaria Marcianò, MSc; Armando A Genazzani, DPhil, MD Abstract: This paper aims to provide an overview… Read More »
Ocular emulsions and dry eye: a case study of a non-biological complex drug product delivered to a complex organ to treat a complex disease
Author(s): Anu Gore, PhD, Chetan Pujara, PhD, Mayssa Attar, PhD, Sesha Neervannan, PhD
Page: 13-23
Author byline as per print journal: Anu Gore, PhD; Mayssa Attar, PhD; Chetan Pujara, PhD; Sesha Neervannan, PhD Abstract: Generic drugs are intended to provide a lower cost option of safe… Read More »