Biosimilars/Research

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].

Biosimilars, are they comparable to their reference counterparts?

Biosimilars/Research | Posted 18/11/2022

Biologicals such as rituximab and trastuzumab have improved treatment outcomes for many cancers. However, due to their high economic burden, ‘highly similar’ products known as biosimilars have been developed and used. Yet, there is still concern surrounding comparability of efficacy and safety between the biosimilar and its reference biological, especially regarding patients switching from the reference to the biosimilar.

The cost savings of non-medical switching in dermatology

Biosimilars/Research | Posted 04/11/2022

Non-medical switching is when a patients' therapy is changed due to reasons not linked to their health and can involve non-interchangeable drugs, potentially affecting the treatment outcomes.