Biosimilars/General

EC publishes improved biosimilars information for patients

Biosimilars/General | Posted 27/01/2017

On 23 January 2017, the European Commission (EC) published a unique question and answer (Q&A) document for patients containing reliable information on biosimilar medicines.

European IBD specialists support switching to biosimilars

Biosimilars/General | Posted 27/01/2017

The European Crohn’s and Colitis Organization (ECCO) has published results of a consensus meeting held on 15 October 2016 in Vienna, Austria in which they support switching from reference infliximab to biosimilar infliximab [1].

European oncologists back biosimilars with position paper

Biosimilars/General | Posted 20/01/2017

On 16 January 2017, the European Society for Medical Oncology (ESMO) published a position paper on biosimilars saying that ‘biosimilars create opportunities for sustainable cancer care’ [1].

What happened in biosimilars during 2015

Biosimilars/General | Posted 22/01/2016

The past year has once again been a busy one for the biosimilars industry [1]. The most important milestone achieved during 2015 was the landmark decision made by the US Food and Drug Administration (FDA) on 6 March 2015 to approve Sandoz’s filgrastim biosimilar, Zarxio (filgrastim-sndz), for all five indications of the originator product (Neupogen). FDA is also reviewing applications for epoetin alfa, infliximab, etanercept filgrastim and pegfilgrastim biosimilars.

US$67 billion worth of biosimilar patents expiring before 2020

Biosimilars/General | Posted 29/06/2012

Last updated: 20 January 2014

Twelve biological products with global sales of more than US$67 billion will be exposed to biosimilar competition by 2020, with Enbrel (etanercept) whose US patent has been extended until 2028, scoring global sales of US$7.3 billion by December 2011; coming in second after Humira (adalimumab) with global sales of US$7.9 billion [1].

Position statement on approval of biosimilars in Latin America

Biosimilars/General | Posted 10/02/2017

The Fifth Latin American Forum on Biosimilars (FLAB) was held in Brasilia, Brazil in 2015 with the theme of ‘Interchangeability and Automatic Substitution’. Discussions centred on the approval of CT-P13, an infliximab biosimilar; and RTXM83, a proposed rituximab biosimilar, in both Brazil and Argentina. Following these discussions, Babini et al. [1] published a FLAB position statement on the approval of these monoclonal antibody biosimilars in the context of current regulations in these two Latin American countries.

Biosimilars applications under review by EMA – December 2016

Biosimilars/General | Posted 13/01/2017

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

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.

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).

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.