Biosimilars
EMA approval for biosimilar insulin glargine Semglee
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 25 January 2018 that it had recommended granting marketing authorization for the insulin glargine biosimilar Semglee.
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].
Quebec adds biosimilar etanercept Erelzi to public drug plan
In August 2017, Sandoz, the generics division of Novartis, announced that its etanercept biosimilar, Erelzi, was now available in Canada [1], after the company received Health Canada approval for the biosimilar in April 2017. Quebec is now the most recent Canadian province to add Erelzi to its public drug plan for the treatment of multiple inflammatory diseases.
Structure-function relationship between disulfide bonds and TNF-α neutralization in etanercept
Research carried out by Sandoz describes how a novel incorrect disulfide bridge structure present at low levels in commercial etanercept inhibits etanercept potency by reducing its ability to neutralize soluble tumour necrosis factor alpha (TNF-α) [1].
Denosumab biosimilar being developed in Australia
Australian biologicals company NeuClone disclosed on 5 January 2018 the fifth biosimilar candidate that the company is developing in its pipeline of monoclonal antibody (mAb) products. The product is a biosimilar candidate for denosumab and is currently in preclinical development.
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].
EC approval for bevacizumab biosimilar Mvasi
Biotech giant Amgen announced on 18 January 2018 that it had received European Commission (EC) approval for its biosimilar bevacizumab product Mvasi (ABP 215).
FDA accepts applications for adalimumab and trastuzumab biosimilars
Samsung Bioepis and Sandoz announced on 20 December 2017 and 16 January 2018, respectively, that the regulatory submissions for their proposed trastuzumab (SB3) and adalimumab (GP2017) biosimilars had been accepted by the US Food and Drug Administration (FDA).
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].
