Biosimilars/Research
Malaysian hospital pharmacists’ perspective on and role in promoting biosimilars use
This survey study carried out by Mohd Sani N et al. aimed to evaluate Malaysian pharmacists’ perspectives of biosimilars and to determine factors associated with pharmacists successfully promoting their use.
Survey demonstrates US pharmacist biosimilar knowledge gaps
Previous studies of stakeholder perceptions have primarily focused on physicians. However, pharmacists are key stakeholders in the use and adoption of biosimilars. The study carried out by Stevenson et al. sought to gain insights from US pharmacists about their knowledge and approach to the use of biosimilars.
Best-value biological selection making: more to consider than only price
A recent paper by Barbier et al. described the criteria to be considered when selecting best-value biological, emphasizing that more factors should be taken into account than only the price, and the authors proposed an updated approach - a model, and guidelines to assist healthcare professionals to make transparent and evidence-based decisions [1].
A global overview of manufacturers of follow-on biologicals
Recently, the World Health Organization (WHO) has pointed out that the absence of appropriate regulatory frameworks for biosimilars may have led to the approval of follow-on biologicals that cannot be considered biosimilars according to current WHO biosimilar guidelines, which were coined ‘non-innovator biologicals’ by WHO. In order to investigate the existence of ‘non-innovator biologicals’ in global markets, more understanding of the structure of the market and the manufacturers that are active in this field is needed.
DARS: advancing biosimilar development in the US
This article reviews the recent engagement of the Division of Applied Regulatory Science (DARS) in several current initiatives on utilizing pharmacodynamic (PD) biomarkers to demonstrate biosimilarity, potentially streamlining or negate the need for comparative clinical studies.
Pegfilgrastim biosimilars in US supportive oncology
Humphreys et al. published a narrative review article concerning the administration options and the economic considerations of biosimilar pegfilgrastim in supportive cancer treatment in the US to maximize patient benefit[1].
Survey results of biosimilars use among Spanish physicians and pharmacists
Marín-Jiménez I et al. published in April 2021 a report based on a survey that was launched in Spain between June and November 2020 among hospital pharmacists and specialty physicians (dermatology, rheumatology, gastroenterology) to analyse knowledge, perceptions, attitude, barriers and facilitators of biosimilars uptake. Response rate was close to 100%.
US vs Germany and Switzerland: US biosimilars market lags with higher prices
In Germany and Switzerland, more biosimilars were marketed and at lower prices than in the US between 2011 and 2020, finds a JAMA Network Open article [1].
Drug survival of adalimumab biosimilars in psoriasis treatment in Spain
A review by López-Ferrer A et al. entitled ‘Drug survival of adalimumab biosimilars in real-world treatment of psoriasis: A Spanish multicenter study’ provided perspective of the factors associated with biosimilar adalimumab survival in Spain [1].
Investigating cell, tissue and gene therapy products and their regulation
Cell, tissue and gene therapy products or (CTGTPs) are often breakthrough therapies with immense potential in treating diseases with no cure or rare diseases with high treatment burdens. However, few of such therapies have been approved and some have been recalled due to safety issues. Now, a study published in GaBI Journal [1] has investigated these therapies and the manufacturing and regulatory challenges they pose.
