Biosimilars

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’.

Study design for biosimilar trials

Biosimilars/Research | Posted 28/10/2016

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].

Biogen’s infliximab biosimilar gets UK launch

Biosimilars/News | Posted 28/10/2016

US biotechnology company Biogen has launched their biosimilar of blockbuster anti-inflammatory Remicade (infliximab) across the UK.

NOR-SWITCH study finds biosimilar infliximab not inferior to originator

Biosimilars/Research | Posted 21/10/2016

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

Biosimilars/Research | Posted 21/10/2016

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].

Pfizer to launch infliximab biosimilar Inflectra in US

Biosimilars/News | Posted 21/10/2016

Pfizer announced on 17 October 2016 that it will begin shipment of its monoclonal antibody biosimilar Inflectra (infliximab-dyyb) to the US in late November 2016.

Merck launches biosimilars educational resource for patients

Biosimilars/General | Posted 21/10/2016

US pharma giant Merck (known as MSD outside the US and Canada) has launched an online resource intended to be used as an educational platform for patients, caregivers and the healthcare community.

Use of biosimilar anti-TNF in Australia

Biosimilars/Research | Posted 14/10/2016

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].

Teva and Celltrion to partner on biosimilars

Biosimilars/News | Posted 14/10/2016

Israeli generics giant Teva Pharmaceutical Industries (Teva) and South Korean biotechnology company Celltrion announced on 7 October 2016 that they had entered into an exclusive partnership for two of Celltrion’s monoclonal antibody biosimilars in the US and Canada.