Use of Biosimilars: A Systematic Review of Published Position Statements and Recommendations from Health Organisations and Societies.

Background: Hesitation about using biosimilars still exists among healthcare professionals (HCPs), despite extensive experience with their use. Globally, several health organisations and societies from various specialties have issued biosimilar position statements to guide the use of biosimilars in their specialties. However, it is uncertain how similar or different their positions or recommendations are or whether these positions have evolved with the increased experience and availability of new evidence.

The use of technology in vaccine safety communication: A systematic review of randomised controlled trials.

Objectives: To identify technologies used in vaccine safety communication and evaluate their impact on vaccination intention, uptake, knowledge, attitude, and perceptions of consumers.

Methods: We searched 6 electronic databases to identify randomised controlled trials assessing the impact of using technology in vaccine safety communication. The Cochrane Collaboration's tool for assessing risk of bias was used to evaluate each study.

Malaysian Hospital Pharmacists' Perspectives and Their Role in Promoting Biosimilar Prescribing: A Nationwide Survey.

Background: With the increasing availability biosimilars, the role of pharmacists as drug information specialists has expanded to include promoting biosimilar acceptance among prescribers.

Objectives: Our study aimed to determine Malaysian hospital pharmacists' perspectives on biosimilars and to identify factors influencing the successful promotion of biosimilars to prescribers.

Methods: This was a cross-sectional, web-based survey of hospital pharmacists across Malaysia.

Pharmacists' Perspectives of Biosimilars: A Systematic Review.

Background And Objective: While biosimilars are less expensive than their originator biologics, various factors are known to impede their uptake in clinical practice including concerns regarding their interchangeability, efficacy, and safety. Pharmacists are well positioned to promote the adoption of biosimilars, thus, the aim of the review was to assess pharmacists' knowledge and perceptions of biosimilars to identify the need for pharmacist-directed biosimilar education.

Methods: We conducted a systematic literature search for published articles indexed in MEDLINE via EBSCOHOST, Web of Science, Scopus, Cochrane Library, Dimensions, and Google Scholar databases.

Cell and gene therapy products in Malaysia: a snapshot of the industry's current regulation preparedness.

Background Aims: Cell and gene therapy products (CGTPs) are anticipated to bring many benefits for the treatment of conditions with limited or no satisfactory treatment options. However, they are associated with concerns of potential safety risks because of their high complexity. The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia took the first step toward the regulation of CGTPs by publishing the Malaysian Guidance Document and Guidelines for CGTPs in 2016.

Biosimilars in Malaysia: Regulatory Framework, Approved Products, and Adverse Effects.

Introduction: Biosimilars are a cost-effective alternative to original biologic medicines that allow patients access to biologic therapies for various chronic diseases. Our paper aims to provide an overview of biosimilars in Malaysia with emphasis on the comparison of Malaysian guidelines with guidelines from well-established regulatory agencies, a review of biosimilars' market approval and their reported adverse effects (AEs) as well as clinical trials conducted in Malaysia.

Methods: We searched the official websites of the National Pharmaceutical Regulatory Agency (NPRA) Malaysia and three other well-established agencies, online databases of Medline® and EMBASE for guidelines on legislation and regulations of biosimilars.

Correction to: An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology.

The authors have revised Figure 1. The revised figure is presented below.

An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology.

Introduction: The National Pharmaceutical Regulatory Agency (NPRA) embarked on a regulatory-strengthening program and is evaluating its processes. Optimising Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that provides benchmarking data that can define performance targets and focus performance improvement. The objective of this study was to use OpERA methodology to determine where time is spent in the NPRA approval process and to form a baseline to measure the performance improvements.