Biosimilars/Research
Quality and clinical performance of biopharmaceuticals
A review carried out by researchers from Sandoz describes the inherent nature of biopharmaceutical heterogeneity and discusses modern quality systems and regulatory frameworks used to maintain biopharmaceutical quality and clinical performance [1].
Zarxio reveals all: the US biosimilars market
Launched in 2015, Zarxio (filgrastim-sndz) was the first biosimilar to gain US Food and Drug Administration (FDA) approval [1]. It competes with Neupogen (its reference product), Granix and Neulasta, for a share of the neutropenia market. This approval came almost a decade after the 2006 launch of the first biosimilar in Europe. Following this, a new study has examined Zarxio’s first years’ performance in the US short-acting (SA) filgrastim market to identify key sales and marketing trends and their drivers [2].
The biosimilar landscape in Italy revealed
In Italy, health services are run at the regional level. To date, there has been no systematic monitoring of the uptake of biosimilars at a national or regional level. As such, the biosimilar landscape in Italy has not been well understood. However, a recent paper now provides an overview of the available real-world data relating to the patterns of use and the comparative effectiveness of biosimilars and originator biological drugs in Italy [1].
Danish etanercept switching study investigates withdrawal rates
A study carried out by researchers from Denmark has investigated switching from originator to biosimilar etanercept 1-year post switch [1].
Switching to biosimilars in rheumatology
Researchers from Argentina, Brazil, Germany, the UK and the US investigated switching from originator biologicals to biosimilars [1].
Additional clinical data for Cinfa’s pegfilgrastim biosimilar
Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 2 November 2017 additional clinical data for its candidate pegfilgrastim biosimilar (B12019).
Switching failures with biosimilar etanercept
A study carried out by researchers from Denmark has found that switching from originator to biosimilar etanercept does not work for all patients [1].
Reimbursement for oncology biosimilars in the US
How reimbursement issues for biosimilars might affect US oncologists was a subject discussed by Dr Rena Conti, Associate Professor of Health Policy and Economics in the Department of Paediatrics at the University of Chicago, USA [1].
Impact of follow-on biological products in the Brazilian health system
Cancer is an epidemic disease in the 21st century. However, despite consistent increases on its incidence worldwide, mortality rates have fallen, especially in developed countries [1, 2]. The victories mankind has achieved in the war against cancer result from advances in different fields, such as early diagnosis and better surgical, radiotherapeutic and systemic treatments.
Hospital specialists and pharmacists surveyed about biosimilars
Biological medicines are essential for many acute and chronic conditions, but their consumption differs widely among European countries [1, 2]. In contrast with the procedures for their approval [3], position papers from scientific societies suggest that biosimilars need to be tested in well-designed, randomized, controlled clinical trials, especially for extrapolation of indications [4, 5]. Nevertheless, switches with originators are becoming common and no serious adverse effects have been reported to date [6-8].
