Home / Biosimilars / Research

Research

Biosimilars in nephrology in the US

Biosimilars are biological medicines that are highly similar to the reference product with no meaningful clinical differences in terms of safety, purity and potency. All biologicals are produced by living cells resulting in an inherent heterogeneity in their higher order structures and post-translational modifications.

Standardizing clinical trials for biosimilars

Researchers from the University of Massachusetts, USA and Newcastle University, UK argue that clinical trial design should be standardized for future studies of biosimilars [1]. Indeed, they argue that a ‘standard clinical trial design be adopted for all biosimilars of a particular [originator biological] in a given disease’.

Study design for biosimilar trials

Biosimilars have been available in the field of rheumatology since 2015. In light of this fact, researchers from the National Health Service (NHS) Foundation Trust and King’s College London, discuss study design for biosimilar trials [1].

NOR-SWITCH study finds biosimilar infliximab not inferior to originator

Results of a two-year phase IV study have shown that Celltrion Healthcare (Celltrion)’s infliximab biosimilar (Remsima, CT-P13) is not inferior to the originator biological Remicade.

Biosimilars versus generics

Since 2015, biosimilars have been available in the field of rheumatology. Researchers from the National Health Service (NHS) Foundation Trust and King’s College London discuss how such biosimilars differ from the more traditional generics [1].

Biosimilars: clinicians and regulators need to talk

In Europe, there is a clear gap between the regulatory decisions that govern biosimilar approval and the recommendations of medical societies. The fact that the views of medical societies, whose members are the physicians that will prescribe biosimilars, disagree with those of regulators, may hold back biosimilar uptake. 

Use of biosimilar anti-TNF in Australia

With the advent of biosimilar anti-tumour necrosis factor (TNF), new options have opened up for the treatment of inflammatory bowel disease (IBD) in Australia. Author Richard B Gearry of the University of Otago, Christchurch, New Zealand, discusses what needs to be taken into consideration when physicians prescribe anti-TNF products [1].

Positive phase III results for Mylan’s biosimilar pegfilgrastim

Results of a study of Biocon and Mylan’s comparing Biocon/Mylan’s biosimilar pegfilgrastim (MYL-1401H) to the originator (Neulasta) has ‘demonstrated equivalent efficacy’, according to Mylan [1].

Biosimilars in rheumatology

In 2015, the rheumatology community saw the emergence of the first biosimilars onto the market. Biosimilars are not new to the medical community at large, having been on the market in the European Union (EU) since 2006. However, their arrival into the field of rheumatology is new and, according to researchers from the National Health Service (NHS) Foundation Trust and King's College London, ‘comes with great anticipation’ [1].

Switching may not be suitable for patients with immunogenicity

Results of a study of antibodies to infliximab comparing both the originator (Remicade ) and biosimilar (Inflectra/Remsima; CT-P13) versions has shown ‘cross-immunogenicity’ between the originator and biosimilar in patients with rheumatic diseases [1].

Generics News Research General

more

Biosimilars News Research General

more