Home / Biosimilars / Research

Research

Biosimilars help reduce the costs of cancer care

The costs for cancer drugs have been increasing significantly in countries around the world. With the arrival of new therapies, the future of cancer care is exciting. But how will healthcare systems be able to pay for such innovations? In their commentary, Goldstein and co-authors discuss how biosimilars could help alleviate such challenges [1].

Safety differences in clinical trials for biosimilars

Differences in safety evaluations and findings between clinical trials for biosimilars are highlighted by researchers from the University of Massachusetts, USA and Newcastle University in the UK. This they argue is a reason for clinical trial design for biosimilars to be standardized [1].

Assessing analytical comparability for G-CSF biosimilars

According to the US Food and Drug Administration (FDA), a biosimilar is a biological product shown to be ‘highly similar to an FDA-approved biological product’, and which ‘has no clinically meaningful differences in terms of safety and effectiveness’. Only minor differences in clinically inactive components are allowable in biosimilars. Biosimilars of approved biologicals at the end of their patent life are expected to cost less but be as safe and effective for licensed clinical uses. To date, FDA has approved four biosimilars [1], while the European Union has approved more than 20 biosimilars [2].

Extrapolation of indications for biosimilar infliximab and etanercept

Biosimilar infliximab (Inflectra/Remsima) was approved in Europe in September 2013 for the same indications as the originator product (Remicade). More recently, biosimilar etanercept (Benepali) was approved in Europe in January 2016 for the same indications as the originator product (Enbrel) [1]. Researchers from the National Health Service (NHS) Foundation Trust and King’s College London, discuss the extrapolation of the indications for the biosimilars [2].

Trials for biosimilar etanercept

Biosimilar etanercept was approved in Europe in January 2016 [1]. Researchers from the National Health Service (NHS) Foundation Trust and King’s College London, discuss the trials that led to the approval of biosimilar etanercept [2].

Differences in efficacy assessment in clinical trials for biosimilars

Clinical trial design should be standardized according to researchers from the University of Massachusetts, USA and Newcastle University in the UK [1]. They argue that a ‘standard clinical trial design be adopted for all biosimilars of a particular [originator biological] in a given disease’.

Trials for biosimilar infliximab

Biosimilar infliximab was launched in the UK in March 2015. Researchers from the National Health Service (NHS) Foundation Trust and King’s College London, discuss the trials that led to the approval of biosimilar infliximab [1].

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].

Generics News Research General

more

Biosimilars News Research General

more