Biosimilars/Research
Generics versus biosimilars: pricing and usage-enhancing policies
In Europe, pricing and demand-side measures for generic medicines are widely implemented and have undergone evaluations [1-4]. However, when it comes to biosimilars, the policies implemented by European countries are less well known and explored.
Etanercept switching study investigates non-mandatory transitioning
A study carried out by researchers from The Netherlands investigated whether non-mandatory transitioning from originator to biosimilar etanercept improves retention rates [1].
EBE reveals Europe’s biosimilar pricing and reimbursement policies landscape
The first biosimilar was approved in the European Union (EU) in 2006. Since then, biosimilar policies have been developed with a focus on increasing biosimilar uptake. However, the extent to which EU Member State polices differentiate between biosimilars and generic medicines has been brought into question. The European Biopharmaceutical Enterprises (EBE) has conducted a second survey on pricing and reimbursement policies for off-patent biologicals to map the biosimilar policy landscape in Europe [1].
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].
