Biosimilars

Assessing analytical comparability for G-CSF biosimilars

Biosimilars/Research | Posted 25/11/2016

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].

Portuguese dermatologists’ position on the use of biosimilars in psoriasis

Biosimilars/General | Posted 25/11/2016

Biologicals have revolutionized the treatment of psoriasis and psoriatic arthritis. However, they impose a heavy burden on the healthcare system due to their high costs. In 2013, 27% of pharmaceutical sales were for biologicals. In 2015, two of the top five best-selling therapies were tumour necrosis factor-alpha (TNF-α) inhibitors, adalimumab and etanercept. Biosimilars, which may cost 25−30% less than the originator biological, thus represent a significant opportunity for savings to be made by both patients and healthcare systems.

Extrapolation of indications for biosimilar infliximab and etanercept

Biosimilars/Research | Posted 18/11/2016

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].

EMA approves biosimilars of insulin glargine and teriparatide

Biosimilars/News | Posted 18/11/2016

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 November 2016 that it had recommended granting of marketing authorization for an insulin glargine biosimilar and two teriparatide biosimilars.

Celltrion submits trastuzumab biosimilar application to EMA

Biosimilars/News | Posted 18/11/2016

South Korean biotechnology company Celltrion has, according to The Korea Herald, submitted another biosimilar application to the European Medicines Agency (EMA).

Trials for biosimilar etanercept

Biosimilars/Research | Posted 11/11/2016

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

Biosimilars/Research | Posted 11/11/2016

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’.

FDA accepts application for pegfilgrastim biosimilar from Coherus

Biosimilars/News | Posted 11/11/2016

Coherus BioSciences (Coherus) announced on 6 October 2016 that the US Food and Drug Administration (FDA) had accepted for review a Biologics License Application (BLA) for the company’s pegfilgrastim biosimilar candidate (CHS-1701).

Biosimilars of natalizumab

Biosimilars/General | Posted 11/11/2016

Natalizumab is a humanized monoclonal antibody against the cell adhesion molecule α4-integrin. Natalizumab is believed to work by reducing the ability of inflammatory immune cells to attach to and pass through the cell layers lining the intestines and blood–brain barrier. Natalizumab is indicated for the treatment of multiple sclerosis (US and Europe) and Crohn’s disease (US).

Trials for biosimilar infliximab

Biosimilars/Research | Posted 04/11/2016

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].

Baxalta and Momenta part ways on adalimumab biosimilar

Biosimilars/News | Posted 04/11/2016

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 27 September 2016 that it would regain rights to its candidate adalimumab biosimilar M923 from Baxalta, a spinoff company from Baxter International.

Biosimilars in nephrology in the US

Biosimilars/Research | Posted 04/11/2016

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.

WHO proposes provisional implementation of biological qualifier

Biosimilars/General | Posted 28/10/2016

The World Health Organization (WHO) first introduced the concept of a biological qualifier (BQ) for naming biologicals back in 2014. This was followed by a draft proposal on naming biologicals, including biosimilars [1]. This has now been followed by the proposal to proceed with a provisional implementation of the BQ scheme accompanied by a prospective impact study.

Standardizing clinical trials for biosimilars

Biosimilars/Research | Posted 28/10/2016

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’.