Biosimilars/Research

Best-value biological selection making: more to consider than only price

Biosimilars/Research | Posted 03/02/2023

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

Biosimilars/Research | Posted 16/03/2023

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

Biosimilars/Research | Posted 10/02/2023

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

Biosimilars/Research | Posted 13/01/2023

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

Biosimilars/Research | Posted 06/05/2022

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

Biosimilars/Research | Posted 27/01/2023

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

Biosimilars/Research | Posted 20/01/2023

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

Biosimilars/Research | Posted 12/12/2022

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.

AVT02 biosimilarity with Humira proved in chronic plaque psoriasis treatment

Biosimilars/Research | Posted 01/12/2022

Results of clinical patient trials of Alvotech’s high concentration formulation biosimilar of adalimumab, AVT02, demonstrate comparable efficacy, safety and immunogenicity to the reference product Humira, according to a study published in Biodrugs [1].

Investigating biosimilar product drift and divergence

Biosimilars/Research | Posted 25/11/2022

Following the establishment of biosimilarity, there are no regulations that require manufacturers to perform quality or clinical studies to compare biosimilar versus originator products post-approval. In an investigation published in GaBI Journal [1], Dr Pablo Matar examined the concept of biosimilar manufacturing ‘drift’ and product divergence [2].