Author byline as per print journal: Josette Sciberras, MBA, MA Bioethics, BPharm (Hons); Raymond Zammit, SThD; Patricia Vella Bonanno, PhD Introduction: The Pharmaceutical Strategy for Europe (2020) proposes actions related to intellectual property (IP) rights as a means of ensuring patients’ access to medicines. This review aims to describe and discuss the European IP framework and […]
Author byline as per print journal: Professor Philip J Schneider1, MS, FASHP, FASPEN, FFIP; Michael S Reilly2, Esq Canada has approved a total of 36 biosimilars. While the approval of biosimilars is regulated at the national level, decisions about biosimilar substitution are made at the provincial level. Four Canadian provinces, representing around 50% of the […]
Author byline as per print journal: Adjunct Associate Professor Sia Chong Hock, BSc (Pharm), MSc; Tan Ying Ting, BSc Pharm (Hons); Associate Professor Chan Lai Wah, BSc Pharm (Hons), PhD Hand sanitizers are rub-on formulations for the purpose of inactivating microorganisms on the hands. With the recent COVID-19 pandemic, a surge in the manufacturing, sale […]
Author byline as per print journal: Marta Zuccarelli1, PharmD; Benjamin Micallef1, PharmD; Mark Cilia1, PharmD; Anthony Serracino-Inglott1,2, PharmD; John-Joseph Borg1,3, PhD Introduction/Study Objectives: The development of biosimilars is challenging due to the complexity of the active substances as well as the strict regulatory requirements to show similarity with a reference medicinal product. This review aims […]
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 (CM) is the integration of a series of unit operations, processing materials continually to produce the final pharmaceutical product. In recent years, CM of pharmaceuticals […]
Author byline as per print journal: Farhang Rezaei, PharmD; Nassim Anjidani, PharmD 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 provide an overview of their current status in Iran. Methods: A comprehensive search of […]
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) (Hons), PhD Abstract: Data Integrity, which is data deemed Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA-plus), has been the focus of […]
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 Abstract: Biopharmaceuticals belong to a class of medicinal products whose active pharmaceutical ingredient (API) is manufactured using living systems such as microbial and mammalian cells. […]
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 Andrade2, MD; Damaris P Intriago-Baldeón4, MSc; Claudio Galarza-Maldonado5, MD, PhD Abstract: The number of approved biological medicines in the global pharmaceutical market has increased in […]
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 Hernández-Guadarrama, MD; JI Navarrete-Martínez, MD; Y Santillán-Hernández, MD; E Terreros-Muñoz, MD Abstract: Enzyme replacement therapy (ERT) is the first-line treatment for Gaucher disease (GD). The […]
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 protein biotherapeutics are produced in non-human cells and multiple downstream protocols are employed in the isolation and purification of drug product; consequent micro-heterogeneities may be […]
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; Professor Stephen Byrne1, BSc (Hon) Pharmacy, PhD Background and aim: Biosimilar medicines are not considered exact replicas of originator biological medicines. As a result, prescribers […]
